Associate Director, Statistical Programming

We are seeking an experienced Associate Director of Statistical Programming to provide technical and project leadership in the delivery of high-quality, timely statistical programming for clinical studies and regulatory submissions.

Responsibilities

• Provides technical and/or operational leadership in the delivery of high-quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
• Works closely with Biostatistics to implement statistical analysis of clinical trial data, including the development and validation of CDISC ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Collaborates with Data Management on cross-functional data review and the development and validation of CDISC SDTM specifications, datasets, and define packages. Supports Drug Safety and Clinical Pharmacology in their dataset creation and analytic needs.
• Manages internal and vendor statistical programming support; maintains strong collaboration and governance with preferred vendors.
• Writes SAS and R code to produce or validate tables, listings, figures, and analysis datasets in support of clinical studies or complex integrated analyses for submission.
• Plans and coordinates project work to ensure timely, quality delivery across multiple projects or a drug program.
• Writes specifications to describe programming needs, including development and maintenance of complex ADaM specifications and reviewer guides.
• Leads the creation and validation of global macros or systems to streamline repetitive operations and increase programming efficiency.
• Provides input into or leads standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations).
• Leads efforts to develop programming processes consistent with industry best practices.
• Reviews and provides expert input to DMP, eCRF specs, and other clinical data management documents; reviews and provides input to statistical analysis plans and related documents.
• Partners with or oversees CROs or programming vendors to perform any of the above tasks.

Requirements

• At least 10 years of industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent.
• Experience as a Programming manager (FTEs, Functional Service Providers, or vendors).
• Experience leading programming teams in support of clinical trials, integrated analyses across a program, or preparation of data/analysis for electronic NDA or BLA submission.
• Experience constructing technical programming specifications and producing complex, validated SAS programs.
• Demonstrated experience with CDISC standards, including SDTM and ADaM, and Define.xml.
• Proficiency in SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with demonstrated mastery of SAS/STAT procedures.
• Hands-on experience with R programming for clinical trial data analysis, reporting, and regulatory submissions.
• Knowledge of R packages and frameworks commonly used in clinical development, Posit Workbench (RStudio Server), Posit Package Manager, and enterprise R environments.
• Experience developing SOPs, standards, or implementing programming best practices.
• Experience overseeing vendors in the delivery of quality programming support.
• Excellent written and oral communication and organizational skills.
• Bachelor’s degree required; master’s degree preferred in computer science, statistics, mathematics, or information sciences.

Core Values

• Commitment to People
• Innovation and Discovery
• Sense of Urgency
• Open Culture
• Passion for Excellence

Pay

U.S. pay range: $181,100.00 - $244,900.00. Base pay will be determined based on relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Benefits

• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• Lifestyle reimbursement program.
• Flexible spending and health savings accounts.
• 401(k) with a generous company match.
• Paid time off, wellness days, holidays, and two company-wide recharge breaks.
• Generous family resources and leave.

About Alnylam

We are the leader in RNAi therapeutics—a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered breakthroughs that made RNAi therapeutics possible and is pioneering future innovations. Our deep pipeline and late-stage programs reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture, and commitment to people. We are a globally recognized top employer where an authentic, inclusive culture and breakthrough thinking fuel one another.