Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy, including the CDISC-based sponsor standards library.
Responsibilities
Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy.
Own and evolve the Pierre Fabre Sponsor Standards Library built on top of CDISC standards.
Establish standards governance processes, lifecycle management, version control and change management practices.
Lead the development, maintenance and governance of standards covering eCRF libraries, SDTM, ADaM, edit checks, controlled terminology and study metadata.
Ensure Pierre Fabre standards remain aligned with evolving regulatory expectations and industry best practices.
Requirements
Master's Degree or PhD in life sciences, data management, statistics, programming or a related field
Seeking experienced Senior Statistical Programmers to join the Biometrics Partnership to deliver statistical programming activities across clinical studies, supporting analysis, and regulatory submissions.
Locations (4)
Johannesburg, Gauteng, South Africa
Kenya
Poland
Hungary
Responsibilities
Develop, validate, and maintain complex SAS and R programs for clinical trial analysis and reporting
Lead statistical programming activities for assigned studies, ensuring high-quality and timely delivery
Create and review ADaM datasets, Tables, Listings and Figures (TLFs), and associated programming specifications
Lead statistical programming for assigned compound, managing programming strategy, delivery, and regulatory submissions while maintaining hands‑on SAS/R programming.
Locations (2)
South San Francisco, California, United States
Princeton, New Jersey, United States
Compensation
$183,000—$250,000 USD
Responsibilities
Serve as the compound programming lead, accountable for study- and compound-level programming deliverables
Develop and maintain programming plans, coordinate timelines and resource needs across studies
Lead programming review of SAPs, Data Presentation Plans, and Table Shells
Lead the programming team to produce and/or validate SDTM, ADaM, and TLF deliverables
Manage CROs and contractors supporting the compound
Requirements
Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field
Associate Director, Statistical ProgrammingKardigan · South San Francisco, US+1 more