Associate Director, Statistical Programming
Alnylam Pharmaceuticals
August 23, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
The Associate Director, Statistical Programming provides technical and/or operational leadership to deliver high-quality, timely statistical programming for clinical studies, drug programs, and NDA submissions.
Summary of Key Responsibilities:
- Lead statistical programming activities, ensuring quality and on-time delivery of programming deliverables.
- Develop, maintain, validate, and run quality SAS programs to access, visualize, analyze, and report clinical trial data in line with statistical analysis plans, ICH, and regulatory requirements.
- Partner with Biostatistics on statistical analysis implementation, including CDISC ADaM specifications/datasets and TLFs for regulatory/medical/market access needs.
- Partner with Data Management on cross-functional data review and CDISC SDTM specifications/datasets; may support Drug Safety and Clinical Pharmacology needs.
- Manage internal and vendor programming support; maintain vendor governance.
- Write SAS and R code to produce/validate tables, listings, figures, and analysis datasets for studies and integrated analyses.
- Plan/coordinate project work across multiple projects or a drug program.
- Write programming specifications (including complex ADaM) and reviewer guides; may develop global macros/systems.
- Support standardization efforts and best-practice programming processes.
- Provide expert input to DMP/eCRF specs, clinical data management documents, and statistical analysis plans; oversee CROs/vendors.
Qualifications:
- 10+ years industry SAS programming (Pharma/Biotech/CRO) or equivalent.
- Experience as a programming manager managing FTEs and/or vendors.
- Proven leadership delivering clinical trial programming and supporting eNDA/eBLA submissions.
- Experience with technical programming specifications and complex validated SAS programs.
- Strong CDISC experience (SDTM, ADaM, Define XML) and statistical programming environment understanding.
- Expert knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, SAS/SQL; mastery of SAS/STAT.
- Hands-on R programming for analysis, reporting, and regulatory submissions; knowledge of R packages/frameworks and enterprise R environments (e.g., Posit Workbench/RStudio Server, Posit Package Manager).
- Experience developing SOPs/standards and overseeing vendors.
- Excellent communication and organizational skills.
- Bachelor’s degree required; Master’s preferred in CS, statistics, math, or information sciences.
Summary of Key Responsibilities:
- Lead statistical programming activities, ensuring quality and on-time delivery of programming deliverables.
- Develop, maintain, validate, and run quality SAS programs to access, visualize, analyze, and report clinical trial data in line with statistical analysis plans, ICH, and regulatory requirements.
- Partner with Biostatistics on statistical analysis implementation, including CDISC ADaM specifications/datasets and TLFs for regulatory/medical/market access needs.
- Partner with Data Management on cross-functional data review and CDISC SDTM specifications/datasets; may support Drug Safety and Clinical Pharmacology needs.
- Manage internal and vendor programming support; maintain vendor governance.
- Write SAS and R code to produce/validate tables, listings, figures, and analysis datasets for studies and integrated analyses.
- Plan/coordinate project work across multiple projects or a drug program.
- Write programming specifications (including complex ADaM) and reviewer guides; may develop global macros/systems.
- Support standardization efforts and best-practice programming processes.
- Provide expert input to DMP/eCRF specs, clinical data management documents, and statistical analysis plans; oversee CROs/vendors.
Qualifications:
- 10+ years industry SAS programming (Pharma/Biotech/CRO) or equivalent.
- Experience as a programming manager managing FTEs and/or vendors.
- Proven leadership delivering clinical trial programming and supporting eNDA/eBLA submissions.
- Experience with technical programming specifications and complex validated SAS programs.
- Strong CDISC experience (SDTM, ADaM, Define XML) and statistical programming environment understanding.
- Expert knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, SAS/SQL; mastery of SAS/STAT.
- Hands-on R programming for analysis, reporting, and regulatory submissions; knowledge of R packages/frameworks and enterprise R environments (e.g., Posit Workbench/RStudio Server, Posit Package Manager).
- Experience developing SOPs/standards and overseeing vendors.
- Excellent communication and organizational skills.
- Bachelor’s degree required; Master’s preferred in CS, statistics, math, or information sciences.