Senior Manager, Biostatistics

• 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.
• Collaborates with Statistical Programming on summary and analysis of study data. Writes analysis dataset and ad hoc analysis specifications.
• 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.
• Manages CRO statistical and programming support.

• PhD in Biostatistics, Statistics, or equivalent with at least 5 years' pharmaceutical biostatistics experience; or MS with at least 8 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.

• 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 (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2022, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2023 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer.