Principal Statistical Programmer

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 180,687 - 204,700; Full time

Job summary

Alnylam US, Inc. in Cambridge, MA seeks a Principal Statistical Programmer to develop SAS programs for clinical trial reporting. You will create TLFs, LS, and data sets, ensuring regulatory compliance and efficiency through reusable macros.

The role requires extensive SAS programming experience, CDISC SDTM/ADaM knowledge, and collaboration with CROs to support FDA submissions. Hybrid in-office/remote work is offered in the Cambridge area.

Qualifications

• Bachelor's degree in Engineering/IT/CS or related field and 8 years of related experience.
• Experience developing, validating, and maintaining SAS programs for clinical trial reporting.
• Familiarity with CDISC standards (SDTM/ADaM) and regulatory data handling.

Responsibilities

• Write SAS programs to create tables, listings, figures and analysis datasets.
• Develop and standardize SAS code and reusable macros for efficiency.
• Collaborate with CROs or vendors to ensure timely, compliant deliverables.
• Review SAPs, DMPs, eCRF specs, and other docs for accuracy and compliance.
• Lead programming processes aligned with industry best practices.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Cross-functional teamwork

Education

Bachelor's degree in Engineering/IT/CS or related field

Job description

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.

Pay:

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