Associate Director, Biostatistics

Hybrid

About this role


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.
 
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.
 
 

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Company at a glance

SILENCE DISEASE. AMPLIFY LIFE.™

Alnylam is a leading independent biopharmaceutical company and the pioneer in RNA interference (RNAi) therapeutics – a revolutionary approach to treating diseases which “silences” the genes that cause or contribute to them.

Founded in 2002 by a group of distinguished researchers and biotech leaders, Alnylam’s work over more than two decades has yielded the critical breakthroughs and advancements that have made the field of (RNAi) therapeutics possible. In 2018, our first commercial medicine, and the world’s first RNAi therapeutic was approved. Since then, five more Alnylam-developed medicines have been approved and we’re hard at work developing new therapies to treat both rare and prevalent diseases.

We are a global and diverse company of 2,600+ people. We pride ourselves on fostering a fun, inclusive and dynamic work environment where employees can recognize their fullest potential. That's why we’re consistently ranked as a top employer by The Boston Globe (2015-25), Science Magazine (2018-25), Fast Company (Best Workplaces for Innovators 2020-25) and Great Place to Work.

We are based in Cambridge, Massachusetts (U.S.), with offices throughout North America, Europe, Asia, and South America.

See our social media community guidelines: https://bit.ly/2FcRhJy.

Please note: If you wish to report an adverse event or product complaint, please email [email protected] or you may call us using the following telephone numbers: for North America, 877.ALNYLAM (877.256.9526), for Europe, +31 20 369 7861

Fraudulent Recruitment Activity

Be aware of the potential for scams and fraudulent recruitment activity from individuals claiming to represent Alnylam Pharmaceuticals. Alnylam never conducts its interview process via messaging apps, freelance sites, or social media platforms. Alnylam team members only communicate with potential candidates through an official Alnylam email address ending in "@alnylam.com."

Founded2002
Team Size1,001-5,000 employees
WorkspaceHybrid
IndustryBiotechnology Research
Location
Maidenhead, England, United Kingdom
LinkedInLinkedIn

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