Alnylam Pharmaceuticals · 10 hours ago
Associate Director, Statistical Programming
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$174K/yr - $236K/yr
10+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, committed to transforming lives through innovative science. The Associate Director, Statistical Programming will oversee statistical programming activities for clinical trials, ensuring the quality and timely delivery of programming deliverables while collaborating closely with various teams to support regulatory and medical affairs needs.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
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
Qualification
Required
At least 10 years' 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 to report the results of clinical trials, integrate analyses across a program, or prepare data/analysis for electronic NDA or BLA submission
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
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
Preferred
Experience in R programming
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
2025-12-22
2025-12-20
Company data provided by crunchbase