Posted 7 Feb 2024, 5:00 am

Senior Director Executive Director Statistical Programming at Cullinan Oncology

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.



Summary:

Reporting to the Vice President/Head of biometrics, the Head of Statistical programming will be responsible for leading all statistical analysis and programming for our innovative clinical programs.

This role is based out of the Cambridge Massachusetts office with flexibility for hybrid and/or remote work options. 

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Position Responsibilities:
  • Lead statistical programming activities for all clinical programs
  • Partner closely with Clinical, Operations, Statistics, Data Management and other functions in the execution of clinical trials, statistical analysis reports and publications
  • Select, oversee, and build effective relationships with CROs and other third-party vendors to ensure adequate service provision in statistical programming
  • Oversee statistical programming activities outsourced to CROs including review and check of related SOPs
  • Ensure all the statistical programming work is performed consistent with GCP


Candidate Requirements:
  • BSc or MSc in Statistics, Mathematics, Computer Science or related subjects
  • 15+ years of experience in the pharmaceutical or biotechnology industry; at least 5 years of oncology and/or hematology experience
  • Experience in leading submissions, managing people and overseeing CRO services
  • Extensive knowledge of statistical programming in SAS including Base, Macro, STAT, GRAPH, SQL
  • Profound knowledge of CDISC standards (SDTM/ADAM) and data transfer specifications for third party vendors and third-party data analyses
  • Good knowledge of ICH, FDA/CDE, and GCP regulations and guidelines
  • Strong leadership, interpersonal and communication skills
  • Scientific background and understanding of clinical trials and regulatory compliance
  • Extensive experience overseeing and negotiating successfully with CROs. 


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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.



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Source: Remote Ok