Director, Biostatistics

Relay Therapeutics•Cambridge, MA

6d•$175,000 - $250,000

About The Position

As Associate Director or Director, Biostatistics, you will be accountable for delivery, integrity and quality of Relay Tx’s clinical data analyses across the clinical studies. You will be an integrated member of the Relay Tx clinical development team, responsible for the 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 Biometrics.

Requirements

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 skill 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.

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 team 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