Associate Director

The Opportunity

As Associate Director, Biostatistics, you will be the statistical lead for Relay’s RLY-2608 Phase 3 study anticipated to start in 2025.  You will be accountable for the trial design, integrity and quality of the data for this pivotal clinical study.  You will work with a deeply collaborative clinical development team, and will be responsible for the in-house biostatistics expertise, executing clinical studies that will translate Relay’s innovative science into impactful medicines for patients. You will report to the Senior Director of Biostatistics.

Your role:

• You will function as lead biostatistician for a clinical program and provide technical and business expertise in support of statistical activities.
• You will oversee the day-to-day biostatistics activities, timelines and deliverables for in house biostatistics as well as outsourced services.
• You will be an integral part of clinical study and program team and contribute to various activities from clinical protocol development to statistical analysis plan to clinical study reports.
• You will apply statistical expertise to ensure optimal complex and innovative clinical trial designs, analysis methods and data displays.
• You will ensure scientific integrity of the statistical methodology applied to clinical studies.
• You will collaborate with other functional areas within the company (Clinical Operations, Clinical Research & Development, Clinical Pharmacology, Translational Medicine, Clinical Data Management, Pharmacovigilance, Regulatory and Project Management).  
• You will lead/support the planning and preparation of regulatory submissions- briefing books and integrated summary documents.
• You will support the presentation and publication of clinical trial results and contribution to advances on statistical topics and present at scientific conferences.
• You will help develop department SOPs

Your background:

• You should ideally have a PhD in statistics, biostatistics or related scientific field.
• You have 6+ years of experience in the pharmaceutical/biotechnology industry as a statistician. Oncology experience is highly preferred.
• You have in-depth knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management.
• You have strong programming skills using SAS or R.
• You have working knowledge of CDISC SDTM/ADaM models.
• You have experience in CRO and vendor oversight.
• You are a highly motivated self-starter who is capable of flourishing in a fast-paced small company environment.
• You are a creative problem-solver with excellent communication.
• You have strong interpersonal and organizational skills, with a high degree of attention to detail and ability to interact with cross-functional teams.
• You are flexible to changing priorities, detail-oriented, and work well under pressure.
• You can communicate statistical information to non-scientists and are willing to educate internal team on complex statistical concepts.

** This role is based in Cambridge, MA**

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