Associate Director, Biostatistics

Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials. Contributes to or prepares statistical analysis plans. Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs. Provides statistical guidance on conduct of ongoing trials. Collaborates with Statistical Programmers on summary and analysis of trial data. Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc. Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders Contributes to scientific articles, summarizing data collected in Alnylam trials. Participates in other activities and meetings to support Biostatistics and the Ph.D. in Biostatistics or 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. Interest in and basic understanding of biology and biological processes, including RNAi. Experience in clinical development through Phase 3 (NDA submission). 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 in representing sponsors in meetings with interaction with US FDA and international regulatory authorities. 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 culture: 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 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 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.