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.