At a Glance
- Tasks: Lead statistical activities for clinical trials and collaborate with cross-functional teams.
- Company: Join Alnylam, a pioneer in RNA interference therapeutics with a people-first culture.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Be part of a top employer recognised for innovation and commitment to inclusivity.
- Why this job: Make a real impact in drug development while working with innovative science.
- Qualifications: Ph.D. or MS in Biostatistics with extensive experience in pharmaceutical biostatistics.
The predicted salary is between 75600 - 92400 £ per year.
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.
This is a hybrid position, based two days a week onsite at our offices in Maidenhead.
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 e CRFs.
- 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, ADa M, 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 m RNA 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.
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Associate Director, Biostatistics in Maidenhead employer: Alnylam Pharmaceuticals, Inc.
At Alnylam, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the field of biostatistics. Our Maidenhead office provides a hybrid working model, allowing for flexibility while ensuring strong team engagement. We are committed to employee growth, providing opportunities for professional development and involvement in cutting-edge clinical trials that make a meaningful impact on healthcare.
Contact Details:
Alnylam Pharmaceuticals, Inc. Recruitment Team
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