Associate Director, Biostatistics

Telecommuting: Telecommuting is available (1-3 days per week required in office location in Cambridge, Massachusetts).

Responsibilities:

1. Function as lead biostatistician for a clinical program and provide technical and business expertise in support of statistical activities;
2. Oversee the day-to-day biostatistics activities, timelines and deliverables for in-house biostatistics as well as outsourced services;
3. Serve as an integral part of clinical study and program team and contribute to clinical protocol development, statistical analysis plans, and clinical study reports;
4. Apply statistical expertise to ensure optimal complex and innovative clinical trial designs, analysis methods and data displays;
5. Ensure scientific integrity of statistical methodology applied to clinical studies;
6. 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);
7. Lead and support the planning and preparation of regulatory submissions: briefing books and integrated summary documents;
8. Support the presentation and publication of clinical trial results and contribution to advances on statistical topics and present at scientific conferences; and
9. Help develop department Standard Operating Procedures.

Requirements & Qualifications:

Employer requires a master’s degree in statistics, biostatistics, or a closely related scientific field and six (6) years of work experience as a statistician, or a closely related occupation, in the pharmaceutical or biotechnology industry. In addition, the employer requires the following:

1. Demonstrated knowledge of methodologies applied in clinical trials, with a focus on registration and life-cycle management, gained through at least six (6) years of work experience.
2. Demonstrated ability using SAS or R gained through at least six (6) years of work experience.
3. Demonstrated knowledge of CDISC SDTM/ADaM models gained through at least six (6) years of work experience.
4. Demonstrated knowledge of CRO and vendor oversight gained through at least six (6) years of work experience.
5. Demonstrated ability communicating statistical information to non-scientists in order to educate on complex statistical concepts gained through at least six (6) years of work experience.

All years of experience may be gained concurrently.

Salary range: $154,000 to $230,000 per year.

Applicants can submit their resumes to Relay Theraupeutics, Inc. (Attn: A. Manners), 60 Hampshire St., Cambridge, MA 02139, at [email protected], or apply online here.