Associate Director, Biostatistics
Description
Overview
- 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.
- 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.
- 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.
#LI-LR1 #LI-HYBRID
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 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 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.
Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
Skills
As published by greenhouse · 11 questions
Basics
First Name, Last Name, Email, Phone, Resume/CV, Cover Letter, Location
Short answers (2)
- Preferred First Name optional
- If you answered 'Yes' for above question, please briefly describe the nature of the potential conflict, without providing names or other identifying information unless specifically requested. optional
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- Please confirm that you have reviewed Alnylam's Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.
- Are you legally authorized to work in the country/region of the job for which you are applying?
- Will you now or in the future require sponsorship for an employment Visa?
- Have you previously been employed by Alnylam?
- Do you currently serve as an officer, director (including board of directors or scientific advisory board), principal, or employee of, or consultant to any company that competes with Alnylam (e.g., a competing business in RNAi), purchases goods or services from Alnylam, or sells goods or services to Alnylam, or do you have a personal investment constituting over 1% ownership of any such entity?
- Are you aware of any personal or family relationship that could reasonably give rise to an actual or potential conflict of interest in connection with the position for which you are applying at Alnylam?
- Are you currently performing work at Alnylam via contract, internship, co- op or consultancy?
- Are you currently or have you ever been a healthcare provider or government official?
- Please review and acknowledge the following: