Principal Statistical Programmer Partners Data Systems
Cambridge, MA

Job Description

Principal Statistical Programmer

Overview

Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNA interference (RNAi) into a new class of innovative medicines with the potential to transform the lives of people with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system diseases with unmet need. Our first medicine, the first-ever RNAi therapeutic, has recently been approved by the FDA in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults and by the European Medicines Agency in the EU for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy. In addition, Alnylam has four investigational medicines in late-stage development. www.alnylam.com. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work in 2015, 2016, 2017 and 2018- four years in a row!

We are seeking expert-level hands-on principal programming support and technical leadership to develop, maintain, validate and run SAS computer programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and applicable regulatory requirements. The ability to work independently and expert SAS/GRAPH programming experience is required.

Summary of Key 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;
* Other duties as assigned.

Qualifications

* At least 8 years' industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
* Knowledge of clinical trials and experience in using SAS Enterprise Guide to report the results of clinical trials and/or integrated analysis for submission;
* Experience in constructing technical programming specifications and producing complex, validated SAS programs;
* Strong experience in working with CDISC standards, including SDTM, and ADaM, and Define xml;
* Excellent knowledge of applied statistical methodologies;
* Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
* Good communication and organizational skills required;
* Bachelor's Degree required, Master's Degree Preferred.
* Clear alignment with Alnylam Core Values:

o Commitment to People

o Innovation and Discovery

o Sense of Urgency

o Open Culture

o Passion for Excellence

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.