Associate Director, Biostatistics

Work Category - hybrid

Description

The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

Summary of Key Responsibilities

• Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans.
• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.
• Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
• 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.
• Writes ADS and ad hoc analysis specifications.
• 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
• Development Team as needed.
• Consults with Research & Preclinical colleagues on statistical questions in their work.
• Manages CRO statistical and programming support.

Qualifications

• 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.
• Experience programming in SAS.
• Interest in and basic understanding of biology and biological processes, including RNAi.

Desired Experience :

• Experience in clinical development through Phase 3 (NDA submission).
• Experience as lead statistician for a compound
• 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 representing sponsors in meetings with interaction with US FDA and international regulatory authorities.
• Experience designing and conducting adaptive trials.

About Alnylam

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.