Director / Senior Director, Statistical Programming
Location
United States
Posted
7 days ago
Salary
$250K - $300K / year
Seniority
Lead
No structured requirement data.
Job Description
Director / Senior Director, Statistical Programming
Astera Search
Role Description A well-established, secure and commercially active biopharma is building out its US statistical programming team. This is a senior leadership role that will oversee the build-out of a fully in-house function. - Lead the statistical programming function for the oncology portfolio - Build and develop the new US statistical programming team - Define programming strategy, standards, and processes - Oversee in-house development and validation of SDTM, ADaM datasets, and TFLs - Support regulatory interactions, including IND, NDA/BLA submissions - Collaborate with Biostatistics, Clinical Data Management, and Regulatory on submission readiness Qualifications - Bachelor's or Master's degree in a relevant discipline - Extensive SAS programming experience within pharma or biopharma; oncology background required - Demonstrable experience working directly for a sponsor company - Strong knowledge of CDISC standards (SDTM, ADaM) and FDA/EMA submission requirements - Proven leadership of a programming team or function - East Coast based only Requirements - Compensation DOE - $250,000 - $300,000 base salary + benefits
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