Associate Director, Statistical Programming
Location: Hybrid – 3 days onsite (2 core days + 1 flex day)
Travel: Up to 20%
My client, a growing and innovative biotech organization, is seeking an Associate Director of Statistical Programming to provide expert functional leadership across clinical development programs. This is a highly strategic and hands-on role, overseeing the statistical programming function and supporting critical clinical deliverables from data collection through regulatory submission.
Key Responsibilities:
- Lead statistical programming efforts across complex clinical studies, ensuring regulatory compliance and operational excellence.
- Manage internal programming activities including:
- CDISC-compliant datasets (SDTM, ADaM)
- TFLs for CSRs, DSURs, IBs, and exploratory analyses
- Data cleaning listings and consistency checks
- Establish and maintain programming standards, tools, and SOPs to ensure consistency, efficiency, and quality.
- Collaborate cross-functionally with Biostatistics, Data Management, Clinical, and external vendors.
- Oversee the performance and output of contract programmers, CROs, and external vendors.
- Contribute to continuous process improvement and the qualification of an in-house statistical computing environment.
Requirements:
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related technical field.
- Minimum 10 years of SAS programming experience in pharma, biotech, or CRO settings.
- Advanced SAS expertise including BASE, MACRO, SQL, and plotting procedures.
- Strong proficiency with CDISC standards (SDTM, ADaM, define.xml).
- Excellent communication and problem-solving skills with the ability to work both independently and collaboratively.
- Experience with alternative programming languages or data structures (e.g., R, Python, XML, JSON) is a plus.