Principal Statistical Programmer

Alnylam Pharmaceuticals•,

6d•$180,688 - $204,700•Hybrid

About The Position

This role involves writing SAS programs to produce and validate tables, listings, figures, and analysis datasets for clinical studies and integrated analyses. The position requires adherence to good programming practices, including thorough documentation of SAS code. Responsibilities include performing, planning, and coordinating project work to ensure timely and high-quality delivery across multiple projects. The programmer will use, modify, and maintain existing SAS code, write specifications for programming needs, and create/validate global macros and systems to enhance efficiency. The role also involves staying updated on statistical programming techniques and advancements, assisting in their implementation, and providing input into or leading standardization efforts for various clinical trial reporting elements. Reviewing clinical data management documents and statistical analysis plans is also a key part of the job. The position may involve partnering with or overseeing CROs or programming vendors.

Requirements

Bachelor’s degree in Engineering (any), Information Technology, Information Systems, Computer Science or related field of study
Eight (8) years of experience in the job offered or related occupation
Demonstrated experience providing input into and/or leading standardization initiatives related to case report forms (CRFs), query checks, statistical programming standards, and data presentation formats for Clinical trial reporting
Demonstrated experience reviewing Data Management Plans (DMPs), electronic Case Report Form (eCRF) specifications, and other clinical data management documentation for accuracy and compliance
Demonstrated experience reviewing Statistical Analysis Plans (SAPs) and related clinical study documents to ensure alignment with study objectives and regulatory requirements
Demonstrated experience developing, validating, and maintaining SAS programs to generate Safety and Efficacy tables, listings, figures (TLFs), and analysis datasets for clinical trial reporting
Demonstrated experience modifying, enhancing, and maintaining existing SAS code to support ongoing clinical programming activities and improve efficiency
Demonstrated experience preparing technical programming specifications documenting programming requirements, data derivations, and validation procedures
Demonstrated experience designing, developing, validating, and maintaining reusable global macros and automated systems to streamline repetitive programming tasks and improve operational efficiency
Demonstrated experience utilizing SAS to analyze and report clinical trial data for regulatory submissions and internal review purposes
Demonstrated experience reviewing and developing technical programming specifications and SAS programs in accordance with regulatory and industry standards
Demonstrated experience applying CDISC standards, including SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model), in the preparation and validation of clinical datasets
Demonstrated experience creating eSub package for Clinical trial reporting for FDA submission
Demonstrated experience applying 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

Responsibilities

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.