Associate Director, Biostatistics
Cambridge, MA
Clinical /
Hybrid /
Hybrid
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
This role is responsible for collaborating with both internal and external clinical development teams to provide adequate biostatistics support for all Cullinan projects. This individual will have the unique opportunity to participate in the rapid growth of the biotech clinical development organization.
Position Responsibilities:
- Provide statistical inputs to the life cycle of clinical development for phase I and phase II studies
- Provide oversight and review of statistical documents for multiple projects, including study protocol, SAP, TLF shells, eCRFs, specifications of variable derivations and all deliverables from biometrics vendors.
- Ensure all study level statistical activities are conducted in compliance with regulatory requirements and Cullinan SOPs.
Candidate Requirements:
- PhD in Statistics, Biostatistics or related field
- Oncology or autoimmune experience is required
- 5+ years of experience in biotech, pharmaceutical or CRO
- Knowledge of relevant FDA, EU, ICH guidelines and regulations is preferred
- Strong communication and vendor management skills
- Excellent SAS programming skills
- Desire to work in a fast-paced innovative environment
Cullinan Therapeutics 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.
