Director, Biostatistics at Alnylam Pharmaceuticals in Cambridge, Massachusetts

Job Description:

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, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount's 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg's Gender Equality Index two years in a row (2021-2022), among others. At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

The Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistical sections of protocols, preparing statistical analysis plans, ensuring quality in implementation of statistical analysis, interpreting and communicating the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts, and leading biostatistics support for worldwide regulatory submissions. The Director reports to one of two Senior Directors of Statistics.

Summary of Key Responsibilities

• Leads large and/or complex late phase clinical development program. Represents Biostatistics and the broader Data Sciences and Statistics team including Data Management and Statistical Programming on the Clinical Development Team.
• Mentor statisticians working on the program. Promote teamwork, quality, and innovation through leadership of Data Sciences and Statistics program team meetings. Create a productive work environment. Ensure program team compliance with SOPs and departmental standards.
• Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design innovative clinical trials
• Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
• Reviews and approves stratification/randomization schema
• 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 ADaM and ad hoc analysis specifications
• Interprets and communicates the results of statistical analysis of clinical trial data in support of regulatory submissions as well as manuscripts
• Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
• Leads biostatistics support for worldwide regulatory submissions
• Represents Alnylam in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders
• Contributes to scientific articles, summarizing data collected in Alnylam trials
• Consults with Research, Preclinical, Clinical Pharmacology, Medical Affairs and Commercial colleagues on statistical questions in their work
• Leads and/or assists in development of SOPs
• Exercises leadership within Biostatistics, as well as the broader Data Science and Statistics Expertise Area
• Responsible for resource planning/allocation and timeline management across their clinical development program, and recruiting, retaining, managing, and mentoring biostatisticians
• Manages internal and vendor statistical and programming support.

• Ph.D. in Statistics or Biostatistics or Equivalent with at least 8-10 years pharmaceutical statistics experience (preferred), or Masters in Statistics or Biostatistics or Equivalent with at least 10-12 years pharmaceutical statistics experience
• At least 2 years as a people manager, including authorship of performance evaluations
• 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).
• Understanding of ICH GCP as well as general knowledge of industry best practices and standards
• Proficiency in R programming language
• Experience with CDISC, including SDTM, ADaM, CDASH
• Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities
• Experience in drug development for rare genetic diseases
• Experience with DMPK endpoints and analyses
• Experience designing and conducting adaptive trials
• Experience with Bayesian and/or adaptive clinical trial design and analysis
• 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

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.