Associate Director, Biostatistics

relaytherapeutics; Cambridge (MA); On-site; USD 160,000 - 228,000; Full time

Job summary

Relay Therapeutics is seeking a lead biostatistician to drive statistical strategy across a clinical program. You will oversee the day-to-day biostatistics activities and collaborate with Clinical Operations, Regulatory, and Development teams to design and analyze trials.

You should hold a PhD in statistics/biostatistics and have 6+ years in pharma/biotech with strong SAS/R and CDISC SDTM/ADaM experience. Oncology background is preferred and CRO oversight is expected.

Qualifications

• PhD in statistics/biostatistics or related field.
• 6+ years of experience in the pharmaceutical/biotechnology industry as a statistician.
• Oncology experience preferred.
• Strong programming in SAS or R.
• Working knowledge of CDISC SDTM/ADaM models.
• Experience in CRO and vendor oversight.
• Able to communicate complex statistics to non-scientists.

Responsibilities

• Lead biostatistics activities for a clinical program and oversee in-house and outsourced work.
• Oversee day-to-day biostatistics timelines and deliverables.
• Collaborate with cross-functional teams in protocol development, SAPs and clinical study reports.
• Apply advanced statistical methods and designs for complex and innovative trials.
• Contribute to regulatory submissions briefing books and integrated summaries.
• Assist in department SOP development and budget/resource planning.

Skills

SAS

R

CDISC SDTM/ADaM

CRO oversight

Statistical analysis

Communication

Education

PhD in statistics/biostatistics or related field

Tools

CDISC SDTM/ADaM tools

Job description

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 presents at scientific conferences.
• You will help develop department SOPs
• You will work with the Head of Biostatistics on project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Development Operations management

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 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.

Estimated Salary Range : [ $160,000 - $228,000 ].

The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.

BP1

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,