Associate Director, Medical Affairs Biostatistics

Overview 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. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company’s 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Brazil, the U.K., and Switzerland, Searmount’s 100 Best Companies and Best Companies for Dads, Bloomberg’s Gender Equality Index, among others. The Associate Director, Statistics is responsible for statistical activities in support of Medical Affairs, including contributing to study designs, protocols and analysis plans, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory analyses. Summary of Key Responsibilities - Collaborates with Medical Affairs (Medical Research and Value, Evidence & Strategy), Medical Communications and Publications, Epidemiology and Regulatory to design studies. - Writes the statistical sections of study protocols, while consulting with internal and external experts. - Contributes to or prepares statistical analysis plans. - Collaborates with Data Management and Medical Research on design of eCRFs. - Provides statistical guidance on conduct of ongoing studies. - Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs - Contributes to observational study reports and regulatory documents e.g. DSURs, briefing documents, etc. - Contributes to scientific articles, summarizing data collected in Alnylam studies. - Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed. - Reviews abstracts, manuscripts for publications and presentations - Manages CRO statistical and programming support. Qualifications - PhD in Biostatistics, Statistics, or equivalent with at least 7 years’ pharmaceutical biostatistics experience; or MS with at least 10 years’ relevant experience. - Excellent written and oral communication and presentation skills. - Experience programming in SAS. - Interest in and basic understanding of biology and biological processes, including RNAi. - If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required Desired Experience - Experience in clinical development through Phase 3 (NDA Submission) and post-approval studies. - Understanding of ICH GCP as well as general knowledge of industry practices and standards. - Proficiency in R programming language and other statistical software, including EAST. - Experience with CDISC, including SDTM, ADaM, CDASH. - Experience in drug development for rare genetic diseases. Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.