Associate Director - SDTM programming

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.   

Summary:

The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will also improve Daiichi Sankyo programming efficiency by developing tools and macros and build up standard on SDTM/ADaM datasets, and TFLs.
Responsibilities:
- Supporting project lead on outsourced projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical decision. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) datasets as well as TLFs generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate stud level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.
- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: develop programming submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting
- Develop DSI programming standard template on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, develop, implement, and maintain SDTM, ADaM dataset and TLF standard, develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis
- Develop and maintain necessary programming macros or tools to effectively support all programming needs. Responsibilities include: identify the macros or tools that will facilitate programing efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool implementation and maintenance
- Evaluate, assess and enhance DSI computing environment system. Responsibilities include: continue assessing DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and propose/develop system utilities

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 preferred
- Master's Degree preferred Experience Qualifications
- 10 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred
- 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred
- Previous experience supporting SAS macro and/or system utility development 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
- Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred
- Solid background in applied statistics preferred
- Solid knowledge of new advanced statistical methods using SAS and R preferred
- Advanced knowledge in database structures and set-up preferred

Travel: Ability 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.