Executive Director / Vice President, Head of Biometrics
Cullinan Oncology
United States
Posted on Wednesday, September 27, 2023
Cullinan Oncology is dedicated to creating new standards of care for patients with cancer.
We innovate without borders to find the most promising clinic-ready cancer therapies, whether from our own discovery efforts or through exceptional engagement with our academic and industry partners.
Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.
Powered by our novel research model, we push conventional boundaries from candidate selection to cancer therapeutic, applying rigorous early experimentation to fast-track only the most promising assets to the clinic and ultimately commercialization.
As a result, our diversified pipeline is strategically built with assets that activate the immune system or inhibit key oncogenic drivers across a wide range of modalities, each with the potential to be the best or first in their class.
Our people possess deep scientific expertise, seek innovation openly, and exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients with cancer.
Reporting to the Chief Medical Officer, the Head of Biometrics will be responsible for the management and ongoing development of the Biostatistics, Programming and Data Management teams as well as actively participate in the development, implementation, and oversight of clinical programs.
The role is based out of the Cambridge Massachusetts office with flexibility for hybrid and/or remote work options.
Position Responsibilities
- Leads the Biostatistics, Data Management, and Statistical Programming functions to support the design and analysis of clinical trials (including FIH and registrational studies) in pursuit of dose-finding, proof-of-concept, and regulatory approval.
- Oversees the design, development, and implementation of biostatistics, data management and programming workflows, and provides technical leadership, development, and supervision of the multi-disciplinary Biometrics team.
- Partners closely with Clinical, Regulatory, Operations, and other functions in the design and execution of clinical trials and regulatory submissions
- Represents the biostatistics function in interactions with health authorities institutional review boards, and internal executive leadership
- Responsible for the overall quality of all statistics, statistical programming, data management design, analysis, and reporting deliverables.
- Directs the design, development, and evaluation of a technical infrastructure to expedite the management, evaluation, and reporting of clinical trials data
- Responsible for leading the Biometrics department team to ensure effective, timely, high quality, and compliant management and delivery of goals and accountabilities across multiple ongoing projects.
- Select, oversee, and build effective relationships with CROs and other third-party vendors to ensure adequate service provision in clinical study and program execution related to biostatics; this includes providing documented oversight and addressing issues and challenges at the study and program levels.
- Oversee biostatistical and statistical programming activities outsourced to CROs including review and check of biostatistical and programming-related SOPs
- Ensures all department work is performed consistent with Good Clinical Practices (GCP)
Candidate Requirements
- Ph. D. in statistics or biostatistics with minimum of 10 years of experience in the pharmaceutical or biotechnology industry; or equivalent combination of academic and industry experience.
- Extensive knowledge of clinical trial development and statistical methodology related to trial design and conduct of clinical studies
- Profound knowledge of CDISC standards (SDTM/ADAM) and data transfer specifications for third party vendors and third-party data analyses
- Experience in oncology or hematology preferred
- Good knowledge of ICH, FDA/CDE, and GCP regulations and guidelines
- Scientific background and understanding of clinical trials, clinical development operations and regulatory compliance
- Strong project management, interpersonal and communication skills
- Extensive experience negotiating successfully with health authorities
Cullinan Oncology is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.