The Principal Statistical Programmer will provide 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 with a strong expertise in SAS/GRAPH programming is required. While SAS expertise is required, experience with R programming, particularly data visualization and exploratory analysis, is strongly preferred.
Summary of Key Responsibilities
* Write 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 and R code;
* Perform, plan and coordinate project work to ensure timely, quality delivery across multiple projects;
* Use, modify, and maintain existing SAS and R 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 to report the results of clinical trials and/or integrated analysis for submission;
* Experience in constructing technical programming specifications and producing complex, validated programs;
* Strong experience in working with CDISC standards, including SDTM, and ADaM, and Define XML;
* Preferred experience in R programming;
* 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.
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