Associate Director, Biostatistics

Relay Therapeutics • Cambridge, MA

7d

About The Position

As Associate Director, Biostatistics, you will be accountable for the delivery, integrity, and quality of Relay Tx’s clinical data analyses across clinical studies. You will be an integrated member of the Relay Tx clinical development team, responsible for in-house biostatistics expertise for the execution of clinical studies that will translate Relay’s innovative science into impactful medicines for patients. You will report to the Head of Biostatistics.

Requirements

• PhD in statistics, biostatistics, or related scientific field.
• 6+ years of experience in the pharmaceutical/biotechnology industry as a statistician.
• In-depth knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management.
• Strong programming skill using SAS or R.
• Working knowledge of CDISC SDTM/ADaM models.
• Experience in CRO and vendor oversight.
• Highly motivated self-starter capable of flourishing in a fast-paced small company environment.
• Creative problem-solver with excellent communication.
• Strong interpersonal and organizational skills, with a high degree of attention to detail and ability to interact with cross-functional teams.
• Flexible to changing priorities, detail-oriented, and work well under pressure.
• Ability to communicate statistical information to non-scientists and willingness to educate internal teams on complex statistical concepts.

Nice To Haves

• Oncology experience is highly preferred.

Responsibilities

• Function as lead biostatistician for a clinical program and provide technical and business expertise in support of statistical activities.
• Oversee the day-to-day biostatistics activities, timelines and deliverables for in-house biostatistics as well as outsourced services.
• Be an integral part of clinical study and program teams and contribute to various activities from clinical protocol development to statistical analysis plan to clinical study reports.
• Apply statistical expertise to ensure optimal complex and innovative clinical trial designs, analysis methods and data displays.
• Ensure scientific integrity of the statistical methodology applied to clinical studies.
• 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).
• Lead/support the planning and preparation of regulatory submissions- briefing books and integrated summary documents.
• Support the presentation and publication of clinical trial results and contribution to advances on statistical topics and presents at scientific conferences.
• Help develop department SOPs.
• Work with the Head of Biostatistics on project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Development Operations management.

Benefits

• Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree