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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About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
