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Associate Director, Statistical Programming
3 months ago
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 120 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.
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 DS safety team on all statistical programming analysis and safety signal detection.
It will also improve safety programming efficiency by developing tools and macros and build up standard on SDTM/ADaM datasets, and TFLs.
Responsibilities- Project lead on programming safety supports for safety signal detection, DSUR, early safety data integration, and safety related adhoc analysis, and be responsible for the programming technical decision. By guiding other internal programmer or by self, perform oversight and programmatic review of analysis generated by statistical programming vendor, ensure correct and effective vendor programming implementation. Responsibilities include make strategic programming decision and planning, review SDTM dataset, 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 as needed and ensure its quality and integrity.
- Provide handson statistical programming support for safety signal detection, DSUR, early safety data integration, and safety related adhoc analysis for inhouse project. Responsibilities include derive integrate safety dataset, perform integrated analysis of safety, generate submission data package if needed, create TLFs, perform adhoc and exploratory analysis requested by safety team, and support regulatory response for safety concerns.
- Develop DSI programming standard for safety (scope include but not limited to DSUR) on datasets and TFLs to improve efficiency and quality. Centralize DSUR analysis within the safety programming team.
- Request from programming technology team to develop necessary programming macros or tools (R or Python) and effectively support safety programming needs. Responsibilities include identify the macros or tools that will facilitate programing efficiency, provide requirements of the macro or tool development, test and accept the macro and tools, implement the macro or tools in safety programming projects.
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 setup preferred
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.
