Senior Statistical Programming Lead for CDISC & NDA

Alnylam Pharmaceuticals, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

The Associate Director, Statistical Programming at Alnylam Pharmaceuticals, Inc. in Cambridge, MA, leads statistical programming activities for clinical trials, ensuring the quality and timely delivery of SAS-based deliverables in accordance with ICH guidelines and regulatory requirements.

The role requires SAS expertise and strong leadership of programming teams, with experience in CDISC standards (SDTM/ADaM) and Define-XML; knowledge of R is strongly preferred for data visualization and

Qualifications

• At least 10 years’ industry SAS programming experience or equivalent.
• Experience as a Programming manager (FTEs, FS Providers or vendors).
• Experience leading programming teams in support of clinical trials to report the results of clinical trials, integrate analyses across a program, or prepare data/analysis for regulatory submissions.
• Experience in constructing technical programming specifications and producing complex, validated SAS programs.
• Demonstrated experience in working with CDISC standards, including SDTM, and ADaM, and Define xml.
• Proficiency in understanding of statistical programming environments, processes, procedures, and roles.
• Excellent knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL with a 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 implement programming best practices.
• Experience overseeing vendors in the delivery of quality programming support.
• Excellent written and oral communication and organizational skills required.
• Bachelor’s Degree required, master’s degree preferred, in areas of computer science, statistics, mathematics or information sciences.
• Clear alignment with Alnylam Core Values: Commitment to People; Innovation and Discovery; Sense of Urgency; Open Culture; Passion for Excellence

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, working closely on the development and validation of CDISC ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs.
• Works closely with Data Management on cross‑functional data review and the development and validation of CDISC SDTM specifications and datasets and define packages, may also support Drug Safety to support safety data review and reporting needs, and/or Clinical Pharmacology to support 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 that produces or validates tables, listings, figures and analysis datasets, in support of clinical studies or complex integrated analyses for submission.
• Performs, plans and coordinates project work to ensure timely, quality delivery across multiple projects, or across a drug program.
• Writes specifications to describe programming needs, including development and maintenance of complex / ADaM specifications and reviewer guides.
• May lead the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.
• Provides input into, or leads general 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 expert input to statistical analysis plans and other related documents.
• Partners with or oversees CROs or Programming vendors to perform any of the above tasks.

Skills

SAS programming

Leadership

CDISC SDTM/ADaM

R programming

Regulatory submissions

Vendor management

SAS/STAT

SAS/GRAPH

Education

Bachelor’s Degree in related field

Master’s Degree preferred

Tools

SAS

R

Posit Workbench (RStudio Server)

CDISC Define-XML

Job description

The Associate Director, Statistical Programming at Alnylam Pharmaceuticals, Inc. in Cambridge, MA, leads statistical programming activities for clinical trials, ensuring the quality and timely delivery of SAS-based deliverables in accordance with ICH guidelines and regulatory requirements.

The role requires SAS expertise and strong leadership of programming teams, with experience in CDISC standards (SDTM/ADaM) and Define-XML; knowledge of R is strongly preferred for data visualization and