Director / Senior Director, Statistical Programming
$250k - $300kFull-time
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
Vacancy posted 14 hours ago
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