Manager, Statistical Programming - SDTM
Join a Legacy of Innovation 110 Years and Counting!
With over 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. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.
The purpose of this job is to oversee statistical vendor deliverables (SDTM Specifications, datasets, define.xml, SDRG, Annotated CRF), perform programmatic review of SDTM datasets generated by vendor, ensure deliverable quality, and expedite the preparation of compound regulatory submission. It will also maintain knowledge of industry standards and regulatory requirements to create and maintain company level SDTM standards.
By leading internal programming contractor or by self, perform programmatic review of SDTM data deliverables generated by statistical vendor, ensure deliverable quality for the pivotal studies, for submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation, Study Data Tabulation Model (SDTM) specification, SDTM dataset, and Pinnacle21 report. Develop independent programs to review SDTM dataset generated by vendor, ensure SDTM datasets are in compliance with CDISC and submission requirement, review submission data package, which includes define.xml and Study Data Reviewers Guide (SDRG) 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 SDTM 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 SDTM deliverables, maintain all required study programming documentation required for Trial Master File (TMF).
Maintain institutional knowledge of CDISC CDASH, SDTM and Therapeutic Area standards. Maintain knowledge of FDA/ICH guidelines, and industry/technology standard practices. Participate in SDTM standards development process. Perform mapping of Global CRF library and create SDTM annotated CRF and develop/update company standard SDTM specifications. Design/ Review the study aCRFs and SDTM specifications as per the company standards, CDISC SDTM guidelines and ensure they meet downstream ADaM and Reporting requirements. Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and Quality checking tools.
Provide SDTM programming support for regulatory submission activities. Support submission team in a quick turnaround agency responses or potential Advisory Committee Meeting.
Develop SDTM automation tools/ macros and implement them for SDTM programming activities. Author, review, and train on department procedures including SOPs, SOIs and Guidance Documents.
- Bachelor's degree from an accredited institution in a technical field such as computer science or mathematics; Master's degree in bio/statistics preferred.
- Bachelor's degree with minimum 7 years (or Master's degree with minimum of 5 years) proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming.
- Advanced working knowledge of SAS programming language used in clinical trials programming.
- Advanced working knowledge of CDISC standards including CDASH, and SDTM/ADaM, and extensive experiences of their implementation in clinical trials analysis.
- Experience developing and/or working with company SDTM standards.
- Knowledge in database structures and set-up.
- General Knowledge of eDC systems and the extracted data formats.
- Knowledge of regulatory requirements for submission and experience creating/reviewing submission deliverables for SDTM.
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.
Manager, Statistical Programming - SDTM
Biostatistics & Data Management