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 15,000 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 support quality assurance of statistical vendor deliverables, including performing programmatic review of analysis datasets and Table, Listing, and Figures (TLFs) generated by vendor, ensuring deliverable quality, and helping to expedite the preparation of regulatory submission. It will also to support statistical analysis during submissions and post-submission regulatory response period by independently developing and/or validating analysis datasets, and TLFs.
- Perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies and integrated analysis, 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 surveillance, 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
- Provide programming supports for submission and help submission team in quick turnaround in exploratory analysis and response to regulatory agencies. Responsivities include: create analysis dataset (including specifications) and TLFs to prepare submission, respond to agencies’ questions, perform ad-hoc analysis requested by clinical team, provide programming supports in potential Oncology Drug Advisory Committee (ODAC)
- Support programming project lead to 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 as the backup of the programming project lead, 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, maintain all required study programming documentation required for Trial Master File (TMF)
- Support building up DSI compound specific programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities include: support developing, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standards, develop/validate sample programs to generate standard ADaM dataset and TLFs, and develop and maintain programming macros to effectively support internal data review and data surveillance.
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 an accredited institution in a science or in a technical field Required
- 4 or More Years Bachelor’s degree with (or Master’s degree with minimum 2 years) proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred
- Advanced working knowledge of SAS programming language used in clinical trials programming. preferred
- Advanced working knowledge of CDISC ADaM, and extensive experiences of their implementation in clinical trials analysis preferred
- Working knowledge of CDISC SDTM preferred
- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. preferred
- Knowledge of drug development. preferred
- Experience in regulatory submission and support preferred. preferred
- Solid background in applied statistics preferred
- Solid knowledge of new, advanced statistical methods using SAS and R is a plus preferred
- Knowledge in database structures and set-up preferred
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.