Director, Biostatistics

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.

Qualifications

* 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

Desired Experience:

* 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

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.