Principal Statistical Programmer

NOTICE OF FILING AN APPLICATION FOR PERMANENT EMPLOYMENT

CERTIFICATION

JOB TITLE: Principal Statistical Programmer

• JOB DUTIES: Write SAS programs that produce or validate tables, listings, figures and analysis datasets,
• in support of clinical studies or complex integrated analyses for submission. Develop and follow good
• programming practices, including adequately documenting SAS code. Perform, plan and coordinate project
• work to ensure timely, quality delivery across multiple projects. Use, modify, and maintain existing SAS
• code. Write specifications to describe programming needs. Create and validate global macros or systems
• that streamline repetitive operations to increase programming efficiency. Keep abreast of current and new
• statistical programming techniques and other applicable technical advancements while assisting in their
• implementation. Provide input into, or lead general standardization efforts (e.g., CRFs, query checks,
• standard statistical programs, data presentations). Assist or lead efforts to develop programming processes
• consistent with industry best practices. Review DMP, eCRF specs, and other clinical data management
• documents. Review statistical analysis plans and other related documents. Partner with or oversee CROs or
• programming vendors to perform any of the above tasks. Hybrid in-office/remote position.
• MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: Bachelor’s degree in
• Engineering (any), Information Technology, Information Systems, Computer Science or related field of
• study and eight (8) years of experience in the job offered or related occupation in which the required
• experience was gained. Must have demonstrated experience with: Provide input into and/or lead
• standardization initiatives related to case report forms (CRFs), query checks, statistical programming
• standards, and data presentation formats for Clinical trial reporting; review Data Management Plans
• (DMPs), electronic Case Report Form (eCRF) specifications, and other clinical data management
• documentation for accuracy and compliance; review Statistical Analysis Plans (SAPs) and related clinical
• study documents to ensure alignment with study objectives and regulatory requirements; develop, validate,
• and maintain SAS programs to generate Safety and Efficacy tables, listings, figures (TLFs), and analysis
• datasets for clinical trial reporting; modify, enhance, and maintain existing SAS code to support ongoing
• clinical programming activities and improve efficiency; prepare technical programming specifications
• documenting programming requirements, data derivations, and validation procedures; design, develop,
• validate, and maintain reusable global macros and automated systems to streamline repetitive programming
• tasks and improve operational efficiency; utilize SAS to analyze and report clinical trial data for regulatory
• submissions and internal review purposes; review and develop technical programming specifications and
• SAS programs in accordance with regulatory and industry standards; apply CDISC standards, including
• SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model), in the preparation and validation
• of clinical datasets; create eSub package for Clinical trial reporting for FDA submission; apply statistical
• methodologies and programming techniques to support the analysis, interpretation, and reporting of clinical
• trial data; SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT.
• OTHER: Employer: Alnylam US, Inc.
• Job location: 675 W Kendall Street, Cambridge, MA 02142. Hybrid in-office/remote
• position.
• 40 hours/week; $180,687.50 - $204,700.00/year (view contact information below)
• If offered employment, must have legal right to work in U.S. EOE.
• This notice is being posted as a result of the filing for a permanent resident labor certification application

for this job opportunity. Any person may provide documentary evidence bearing on the application to

U.S. Department of Labor

2

Employment and Training Administration

Office of Foreign Labor Certification

200 Constitution Avenue NW, Room N-5311

Washington, DC 20210

• CONTACT: To apply, submit a resume to
• <https://jobs.alnylam.com/careers?start=0&pid=893380660936&sort_by=hot,> OR submit a resume to

<https://jobquest.dcs.eol.mass.gov/jobquest/LandingPage.aspx> OR mail resume to: Alnylam US, Inc., Attn

HR, 675 West Kendall Street, Cambridge, MA 02142.