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Associate Director, Statistical Programming
165582
Posted:
05/05/2025
- 200000 USD - 235000 USD
- South San Francisco, United States
- Permanent
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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:
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Lead statistical programming efforts across complex clinical studies, ensuring regulatory compliance and operational excellence.
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Manage internal programming activities including:
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CDISC-compliant datasets (SDTM, ADaM)
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TFLs for CSRs, DSURs, IBs, and exploratory analyses
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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:
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Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related technical field.
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Minimum 10 years of SAS programming experience in pharma, biotech, or CRO settings.
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Advanced SAS expertise including BASE, MACRO, SQL, and plotting procedures.
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Strong proficiency with CDISC standards (SDTM, ADaM, define.xml).
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Excellent communication and problem-solving skills with the ability to work both independently and collaboratively.
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Experience with alternative programming languages or data structures (e.g., R, Python, XML, JSON) is a plus.
Leila Johnston
Account Director