Manager Salary in Basking Ridge, NJ

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job SummaryThe Manager, Data Programming & Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert for Clinical Data Programming, Reporting, Process, and technology. Accountable for the quality and delivery of the Data Management programming, reporting and visualization, standard, and exception data listings across studies. Scope of work includes oversight and expertise in the design, development, and validation of programs, standard and adhoc reports, standard and exception data listings, and visualizations to support ongoing data review activities, achieve critical study milestones, and gain data insights into our clinical studies. The position requires good understanding of programming methods and techniques, critical thinking, and complex problem-solving skills. This position will require strong collaboration in working with other members of the Biostatistics and Data Management, external CRO partners, and other stakeholders.Responsibilities Serve as a subject matter expert and provide expertise for Database programming, Reporting, and Technology and optimize the use of J-Review, ETL, SAS tools, and others to support business needs.Manage the quality of the data management clinical database programming deliverables including edit checks programming, complex reports, and listings; patient profiles, subject narratives, exception listings, dose modification reports, and other adhoc reports using JReview & SAS as part of standard data validation and reporting package for clinical studies.Develop and/or provide oversight on the programming specifications for the data validation and reporting deliverables; code, test, and document deliverables conforming to programming standards, data quality and governance, and validation policies. Partner with internal and external stakeholders to ensure timely delivery of data management programming, EDC database, external data, data management programming of reports and listings including the use of visualization tools.Design and develop macros, applications, and other utilities to expedite JReview/SAS programming activities. Develop standard programs, templates, reports, data listings, discrepancy reports, and patient profiles to facilitate in the ongoing review of clinical data during study conduct and study closeout.Build, test, and scale-up programs for data validation derivation procedures, data reports, listings, and SAS on Demand relational database extracts for operational use, identification of data outliers, quality inconsistencies, and preparation for analysis.Provide technical guidance and direct programming tasks for Medical Coding activities.Provide Clinical Programming expertise and support for critical and time-sensitive study milestones including interim analysis, and database lock activities. Perform ETL tasks, enhancements, validation, and maintenance of the programs and templates on an ongoing basis.Perform QC, lead unit testing activities, develop validation scripts for user acceptance, manage and execute programs and dry runs as needed, and resolve programming issues proactively. Develop and maintain mapping, and program specifications for standard reports, listings, and visualizations.Maintain database programming checklists and trackers to ensure conformance of high-quality deliverables with the study data validation and reporting package.Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies.Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines. Qualifications: (What are the minimum requirements for the position?)Education BA/BS degree required, MS or equivalent degree preferable.Experience Minimum of 5 years database programming experience and data validation programming in the device/pharmaceutical/CRO industry.Expertise in Clinical Programming, methods, and techniquesExpertise in using standard reporting and data visualization tools including JReview, and SAS tools.Knowledge of industry standard clinical technologies including CTMS, EDC (RAVE, InForm)Knowledge of CDISC data standards.Knowledge and understanding of relational databases.Competencies Clinical Programming, Project Management, and Technical ExpertiseKnowledge of logical data design and data mappingKnowledge of reporting and data visualization tools: JReview, Spotfire, SAS suite and ETL technologyExperience with programming development, validation, execution, maintenance, documentation, and archival of clinical data for regulatory submission is required.Proficient in industry standards, medical terminology, and clinical trial methodologies.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis position is responsible for the quarterly global consolidation, supporting both external reporting and internal management financial reporting for a collaboration program. This position has responsibilities of working closely with various functions within the company and acting as a liaison with the external partner for a smooth consolidation process. Also responsible for managing various studies including late stage budget and forecasting, analysis, strategic planning, internal reporting, and ad hoc reporting and analysis.Responsibilities- Project Planning and Forecasting - Manage and is accountable for the development of Clinical Project Budget templates in support of early phase to late stage clinical studies. Accountable for the control and reporting of GEMRAD approved budgets. On a monthly basis prepare actuals vs. budget spending reports and communicate to relevant team members. Proactively investigate the reasons for any deviations from forecasted spending and provide guidance to the internal project team(s) during the annual and quarterly forecast updates. Manages and is accountable for developing and building strategic planning and forecasting models in support of the organization's Mid-Term Plan (MTP) process.- Consolidation of Reports - Accountable for the ownership of the multi-functional consolidation process and preparation of financial packages to senior management and to external party for the collaboration program. Participate in the review and analysis of quarterly financial results against plan and monitor key changes between current forecasts vs. prior forecast or year over year during each reforecast and budget cycle and present key findings to alliance partner.- Business Partnering - Develops effective working relationships with business partners and influences strategic decisions to align to company objectives. Develops strong business knowledge of the Functions to help find synergies efficiencies across the organization. Challenges the status quo in an appropriate way to find more optimal and cost-effective approaches that are aligned to our strategy.- Building Financial Models - Develop and continue to refine a financial model for all phases of clinical trials. Research and investigate key parameters through quantitative analyses of historical data and assist in designing initiatives and development of analytical capabilities and dashboards needed for short- and long-term planning cycle to satisfy growing demands for faster and more complex analysis required to support company's making decisions.- Analytics - Develops and prepare detailed analysis of variances, risks opportunities, trending analysis along with KPI's. Effectively uses and communicates key findings and presents recommendations to senior management.Special Projects/Change Management - Create and maintain up-to-date process documentation for all tasks; recommend and implement process improvements, as appropriate, to simplify, standardize and streamline efforts.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- Bachelor's Degree Finance/Accounting concentration preferred areas of study or other relevant discipline requiredExperience Qualifications- 4 or More Years Business environment required- 4 or More Years Finance/Accounting experience required- 1 or More Years Support of R&D organization preferredTravelAbility to travel up to 10%. Travel required for accounting conferences/trainings, Global Finance meetings and Project team support.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Manager, Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support and may manage day to day functional excellence activities to include, but not limited to, the project management of workstreams and strategic imperatives, training and onboarding, metrics activities, participate in GCO vendor assessment, and tracking od vendors and assessment status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and trending to shape the future of Daiichi Sankyo clinical trials.Responsibilities- Process Improvement, Innovation and Optimization (IO):-Project manage GCO Strategic Imperatives (SIs) and process improvement workstreams, partnering with cross-functional subject matter experts.-Support the build of industry expertise in innovation and optimization for clinical trials.-Utilize strategic conferences for information mining and networking, engage more with organizations such as Transcelerate, WCG/Avoca, SCOPE, SCRS, DIA, etc.-Work with and/or support subject matter experts to determine needs and build business cases for implementation of IO tools.-Assist with the tracking of vendors - vendor assessment status and final choices, in collaboration with RD Procurement, who leads the vendor assessment process.-Participate with other FxExc teams within Daiichi Sankyo to optimize cross-functional improvements.-Support creation and/or maintenance of templates (tools, guidance documents, execution plans, Visio and/or Project process mapping), and/or Power Pointpresentations, as needed.- GCO Training:-Contribute to the creation and/or maintenance of GCO Onboarding training.-Assist with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification and implementation of learning and training related needs within GCO. Liaise with other functions and stakeholders, asneeded.-Assist with the review of SOPs and training documentation resulting from new processes or process improvements and roll out GCO training and/or lessons learned, as appropriate.- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and workstream implementations for effectiveness.-monitor key metrics and partner with process owners to identify and address gaps/deficiencies, as needed.-track and oversee the progress of GCO initiatives and goals through KPIs and metrics to monitor and evaluate risks/issues across GCO and effectiveness of initiative and/or process implementation.-Work closely with CTBO and Alliance Management to respond to process metrics and trending data to identify gaps, and design/implement process improvements.-monitor and evaluate risks/issues across GCO initiativesQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's degree with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project management requiredExperience Qualifications- 4 or More Years Experience in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, project management) required- Collaboration, influencing, and change management skills in a complex, matrix environment including project management preferred- Experience in clinical trial design and improvement activities, harmonization/optimization, and training and implementation required- Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point), training systems, and metrics dashboarding preferred- Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements preferredTravelAbility to travel up to 10%. For team meetings, conferences, and to support inspections, as appropriate.Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Manager, IT Project Portfolio Management (IT PPM) is expected to contribute to the advancement and management of IT PPM capabilities by providing project & portfolio level support to the Enterprise Program Management Office (EPMO). This Manager will contribute to three key areas:Integrated IT Project Portfolio ManagementPlan for and manage the annual IT planning cycles and ongoing IT demand processesDefine, measure, and report IT portfolio KPIs and metrics to ensure overall portfolio health and identify trends and improvement areasStreamline and work with program and project managers to facilitate their regular reporting processEnsure optimal resource allocation and forecasting to meet IT portfolio objectivesManage the production of executive level reports and visualization of data to help ensure alignment of the project portfolio and department objectives with the organization's strategic goalsAlign with business functions and Finance as neededIT PPM Strategy, Governance, and Stakeholder PartnershipContribute to the evolution of Global and Regional IT PPM governance, processes, and systemsApply understanding of the pharmaceutical industry and the regulatory requirements that apply to IT projectsStrong communication skills to enable proactive outreach to key business and IT stakeholders in advance of key IT PPM process and system milestonesTranslate complex portfolio data and analytics into consumable information for stakeholders by creating storylines in the context of IT and business objectivesPPM Systems, Frameworks, and StandardsContribute to the overall ownership and maintenance of project systems (e.g. ServiceNow ITBM/SPM) and project collaboration platforms (e.g. Asana, Jira, Unipr)Conduct regular, detailed interactions with PPM platform service providers as part efforts to continuously improve those systemsManage projects and workstreams to deliver on major system enhancements and implementationsMaintain standardized IT PM artifacts such as process documentation and project templatesAssist with training Project Managers on the use of project management systems, processes, and templatesThe Manager, IT PPM must have excellent verbal and written communication skills and be comfortable interacting with a variety of functional groups and leaders in all regions. Additionally, experience working on cross functional teams is desired as well as an understanding of facilitating high functioning teams.Responsibilities- Manage and enhance integrated IT Project Portfolio Management capabilities such as annual continuous portfolio planning, periodic reporting and visualization, and alignment with business and finance functions- Contribute to the evolution of Global and Regional IT PPM strategy, governance, and activities supporting stakeholder partnership- Provide stewardship of IT PPM foundations: systems, frameworks, and standards. Train and enable PMs and other IT and business stakeholders to optimize the value of these IT PPM foundations.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- Bachelor's Degree Emphasis preferred in science or engineering, Information Technology or analytics related disciplines required- Master's Degree Master's in Business Administration, Technology Management, Information Systems or related disciplines preferredExperience Qualifications- 4 or More Years relevant business operation, portfolio or resource management, including 3+ year data-centric responsibilities in pharmaceutical or relevant industry required- 4 or More Years Prior experience in management consulting in pharma/biotech and/or enterprise application implementation preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The manager, RPM contributes to the RPM group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement with focus on quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.)Develop less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissionsSupport GRL with scheduling regulatory meetings, preparing agenda and tracking action itemsResponsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondencesSupport DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in developing regulatory sectionsSchedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriateProvide support or coordinate other regulatory activities per direction from GRL and regulatory strategistsShare RPM best practices and contributed to RPM process improvementKeep current with regulatory and scientific regulations, guidelines and initiativesQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree. Preferably in a scientific disciplineAdvance degree (e.g. MS, PharmD, Ph.D) preferredWork Experience4 or more years of overall related experience (education and/or industry) is preferred1 or more years of industry experience within regulatory is preferredOrganized and detailed orientedExcellent oral and written communication skillsAbility to collaborate effectively with key stakeholdersAbility to plan, coordinate and lead activitiesDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Manager, Medical Training will support Global Oncology Medical Affairs (GOMA) TA/franchise in developing and executing global high-quality training programs and ensuring accuracy and scientific balance. As part of the Medical Content & Training (MCT) team, the manager is responsible for conducting comprehensive medical review and approval of medical content and training materials/programs. The Manager leverages his/her functional and technical expertise to assist in improving organizational effectiveness of the MCT function.Responsibilities- Develop training materials and execute global-regional training programs supporting medical strategy, onboarding and launch initiatives.- Partner with internal stakeholders to proactively identify knowledge gaps and training needs, to establish learning curricula ensuring expertise within Medical Affairs teams- Apply learning principles to the execution of training content and events to optimize training quality and effectiveness.- Conduct comprehensive medical review of materials/programs as member of the MCT team. Ensure comprehensive, high quality, medical review and appropriate sign-off/approval of materials/programs in a timely fashion- Collaborate closely with medical and cross-functional teams as needed to discuss content and scientific rigor of materials/programs and to assure alignment in Global /Regional Medical Affairs- Consult with supervisor as needed- Serve as integral member of the Global Medical Affairs Team, to- Staff Medical Information booths at targeted medical conferences- Participate in projects/initiatives within GMA or across functions, as assigned- Support inquiry response, conduct inquiry analyses, develop global Medical Information Reports and assist in providing customer insightsQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- PharmD or PhD preferredExperience Qualifications- Minimum of 1 year experience in a medically-related field including industry experience in Medical Affairs (experience in medical review and/or medical information is strongly preferred). Proven track record of working successfully with cross-functional teams to achieve results.TravelAbility to travel up to 20%Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe Manager, Global Oncology HEOR & RWE will work cross-functionally to implement HEOR and RWE projects for the assigned assets under the direction of a Director or Sr. Director of Global Oncology HEOR & RWE. The person will work with clinical, market access, commercial, regional and medical affairs colleagues to support the clinical development and value creation of the company's oncology assets. Responsibilities include the implementation of outcomes research strategies, health economics research planning, and process improvements to ensure patient access to Daiichi Sankyo's products. This individual will ensure that rigorous HEOR studies are conducted to support the clinical and economic value proposition associated with the Daiichi Sankyo Oncology products. The work involves developing global cost effectiveness and budget impact models and to fill data gaps to support access needs, as well as to design and implement global outcomes research & health economic studies that supports key publications, reimbursement strategies. The person will work closely with other members of the Global Market Access & Pricing department to develop RWE and support market access initiatives aligned to Daiichi Sankyo's products, and represent the department in cross functional working groups and committees from time to time.Responsibilities- HEOR and RWE Deliverables- Support the preparation of global value dossiers which present the product value propositions and the supporting evidence, aligned with the product development strategies and agreed/endorsed by the GPTs, GBTs, Regional HEOR and market access, to realize an optimal value demonstration of the products- Conduct or support HEOR and RWE studies such as early economic models, burden of illness studies, external control arms to support single arm trials, and support the development and analysis of patient-reported outcomes (PRO) instruments in clinical trials- Conduct literature reviews to build payer evidence, economic models, and Global Value Dossiers- Support the analysis of clinical trial data for cost effectiveness models and market specific ad-hoc requests for reimbursement submissions- Conduct RWE studies to support the value story for payers and reimbursement submissions- Support the development of global cost effectiveness and budget impact models for HTA submissions to support reimbursement of indications for Daiichi Sankyo's oncology products- Develop HEOR and RWE communications (e.g. manuscripts, scientific forum presentations, slide decks, symposia), in collaboration with multi-functional teams, to build the peer reviewed published evidence supporting the value propositions for assigned products- Manage vendors in the conduct of HEOR and RWE projects- Evidence Generation Synthesis- Collaborate cross-functionally to gather overview information of target indications including epidemiology, disease burden, unmet needs, cost of illness, and treatment patterns/pathways- Provide and maintain an in-depth understanding of changing Health Technology Assessments, Reimbursement Access environment, payer requirements, and policies of key global markets- Conduct evidence gap assessments in collaboration with global functions and key markets/regions- Stakeholder Engagement- Partner with Regional and Global stakeholders to assess and fill HEOR/RWE evidence gaps- Collaborate with Clinical (RD) to ensure that Payer and reimbursement requirements for key markets are included in the clinical trial / evidence generation plans- Act as an ambassador to drive the access agenda with key stakeholdersQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- Bachelor's Degree in relevant discipline (e.g., health economics, medicine, pharmacy, public health, epidemiology) requiredExperience Qualifications- 4 or More Years Overall related experience or commensurate education/experience required- 1 or More Years experience in HEOR field (in Healthcare, pharmaceuticals industry, or related) required- Oncology experience, preferably with multi-indication compounds as well as with early-stage compounds- Excellent understanding of the clinical development and life cycle of oncology medicines- Strong knowledge of major markets and their PRA and HTA policies: US and Global (Europe required), both private and government setting- Excellent understanding of HEOR and RWE concepts with hands on experience with HEOR methodologies across all phases of the product life cycle- Track record of successful application of HEOR and RWE with key external stakeholders in major international marketsTravelAbility to travel up to 30% Domestic and Global TravelDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryPosition manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third party vendors. This position has strong verbal/written skills, analytical, organizational, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry within one or more therapeutic areas. Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management.ResponsibilitiesLeadership, Direction, and Strategy:Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studiesProject Management:Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting).Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports).Leads and drives the data review process in collaboration with the study team to ensure data qualityParticipates in audits and inspections.Operational Efficiency / Continuous Improvement:Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes.May participate in process improvement initiatives.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)Bachelor's Degree in life sciences or related field (or equivalent experience) requiredMaster's Degree in life sciences or related field (or equivalent experience) preferredRN in life sciences or related field (or equivalent experience) preferredExperience Qualifications4 or more years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) requiredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe purpose of this job is to oversee statistical vendor deliverables, perform programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality.Responsibilities- By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standard, develop sample programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: create TLFs to support submission QAs in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory Committee Meeting- Develop and maintain programming macros to effectively support internal data review and monitoring. Responsibilities include: work with Biostatistics member to define the requirements of efficacy data review, develop macros and support the internal data review and monitoring on an ongoing basisQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- Master's Degree Biostatistics or similar degree required- PhD Biostatistics or similar degree preferredExperience Qualifications- 6+ Years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a masters degree required- 3+ Years of proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with a PhD preferred- Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming. preferred- Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. preferred- Having knowledge of all phases of drug development, including early and late phase clinical development and submission preferred- Having solid background of applied statistics preferred- Solid knowledge of new advanced statistical methods using SAS preferred- Knowledge in database structures and set-up preferred- The candidate should have successfully provided programming expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies preferredTravelAbility to travel up to 10%Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummarySupport Global Competitive Intelligence activities by proactively identifying and reporting intelligence and bringing strategic insights that will reduce uncertainties and help guide optimal business decisions. Primary support of the Global R&D organization, Global Business Development and other corporate functions.Responsibilities- Legally and ethically help monitor, gather, analyze, and communicate actionable, reliable intelligence on the competitive environment in oncology and specialty medicine, particularly supporting the prioritized pipeline. Adhere to SCIP Code of Ethics.- Ensure appropriate intelligence is identified, captured and disseminated throughout the organization including regular intelligence briefings, early warning alerts, strategic decision support in project teams. Leverage advanced CI techniques to drive organizational awareness, decision-making and strategies.- Partner and work in close collaboration with global teams, stakeholders and leadership to understand organizational needs and maintain up to date key intelligence topics/questions (KITs/KIQs).- Construct expert research to support intelligence needs, develop and manage ongoing monitoring activities and perform ad hoc intelligence analysis on demand.- Create dashboards / landscapes, reports and other intelligence deliverables, visualize and customize data, storyboard narratives, and develop clear messaging of intelligence results. Must be proficient with communicating results effectively to leadership.- Partner with library team members and related intelligence functions to continually learn and inspire others in the spirit of development and growth, and share and build on Competitive Intelligence expertise and insights. Represent Daiichi Sankyo in CI professional organizations and congresses.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or university)- Bachelor's Degree in a life science required- Master's Degree preferable oncology or Library Science preferred- PhD preferable oncology) or Library Science preferredExperience Qualifications- 4 or More Years experience in the pharmaceutical industry required- 4 or More Years experience in a competitive intelligence or equivalent function required Licenses and Certifications- Competitive Intelligence Certification preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.