Principal Statistical Programmer

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

Job summary

Alnylam US, Inc. is seeking a Principal Statistical Programmer in Cambridge, MA to write SAS programs that create and validate tables, listings, figures, and analysis datasets for regulatory submissions.

You will develop global macros, document programming work, and coordinate with CROs or vendors. A CS/engineering degree with extensive SAS experience and CDISC standards know-how is required. The role is hybrid in-office/remote.

Qualifications

• Bachelor’s degree in Engineering, IT, IS, or CS; 8 years of related experience.
• Must have experience in standardizing CRFs, query checks, and reporting formats for clinical trials.
• Experience with SAPs, DMPs and eCRF specifications to ensure data accuracy and regulatory compliance.

Responsibilities

• Write SAS programs to generate TLFs and analysis datasets for clinical trials.
• Develop, document, and maintain reusable global macros and automated systems.
• Collaborate with CROs/vendors to ensure timely delivery and data integrity.

Education

Bachelor’s degree in Engineering/Information Technology/Information Systems/Computer Science or related field

Tools

SAS

SAS/SQL

SAS/GRAPH

SAS/STAT

CDISC SDTM

CDISC ADaM

Job description

NOTICE OF FILING AN APPLICATION FOR PERMANENT EMPLOYMENTCERTIFICATIONJOB TITLE: Principal Statistical ProgrammerJOB 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 goodprogramming practices, including adequately documenting SAS code. Perform, plan and coordinate projectwork to ensure timely, quality delivery across multiple projects. Use, modify, and maintain existing SAScode. Write specifications to describe programming needs. Create and validate global macros or systemsthat streamline repetitive operations to increase programming efficiency. Keep abreast of current and newstatistical programming techniques and other applicable technical advancements while assisting in theirimplementation. 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 processesconsistent with industry best practices. Review DMP, eCRF specs, and other clinical data managementdocuments. Review statistical analysis plans and other related documents. Partner with or oversee CROs orprogramming vendors to perform any of the above tasks. Hybrid in-office/remote position.MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: Bachelor’s degree inEngineering (any), Information Technology, Information Systems, Computer Science or related field ofstudy and eight (8) years of experience in the job offered or related occupation in which the requiredexperience was gained. Must have demonstrated experience with: Provide input into and/or leadstandardization initiatives related to case report forms (CRFs), query checks, statistical programmingstandards, and data presentation formats for Clinical trial reporting; review Data Management Plans(DMPs), electronic Case Report Form (eCRF) specifications, and other clinical data managementdocumentation for accuracy and compliance; review Statistical Analysis Plans (SAPs) and related clinicalstudy 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 analysisdatasets for clinical trial reporting; modify, enhance, and maintain existing SAS code to support ongoingclinical programming activities and improve efficiency; prepare technical programming specificationsdocumenting programming requirements, data derivations, and validation procedures; design, develop,validate, and maintain reusable global macros and automated systems to streamline repetitive programmingtasks and improve operational efficiency; utilize SAS to analyze and report clinical trial data for regulatorysubmissions and internal review purposes; review and develop technical programming specifications andSAS programs in accordance with regulatory and industry standards; apply CDISC standards, includingSDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model), in the preparation and validationof clinical datasets; create eSub package for Clinical trial reporting for FDA submission; apply statisticalmethodologies and programming techniques to support the analysis, interpretation, and reporting of clinicaltrial 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/remoteposition.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 applicationfor this job opportunity. Any person may provide documentary evidence bearing on the application to:U.S. Department of Labor2Employment and Training AdministrationOffice of Foreign Labor Certification200 Constitution Avenue NW, Room N-5311Washington, DC 20210CONTACT: To apply, submit a resume tohttps://jobs.alnylam.com/careers?start=0&pid=893380660936&sort_by=hot, OR submit a resume tohttps://jobquest.dcs.eol.mass.gov/jobquest/LandingPage.aspx OR mail resume to: Alnylam US, Inc., Attn:HR, 675 West Kendall Street, Cambridge, MA 02142.