Principal Statistical Programmer in Maidenhead

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines.

Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence. Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, "change the world" kind of people who are ready to say, "challenge accepted" to our mission.

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 experience 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.