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Senior Director, Biostatistics

Company: Cogent Biosciences, Inc.
Location: Cambridge
Posted on: June 12, 2021

Job Description:

Company Description

Cogent Biosciences is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent's lead therapeutic candidate, CGT9486 (formerly known as PLX9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling.

Job Description

As the head of the function, you are responsible for the statistical aspects of clinical trials, including experimental design, statistical analysis, and reporting.

What You Will Do:

  • You are an experienced, progressive biostatistician and can work collaboratively within the broader Cogent team in the planning and analysis of clinical studies.
  • You will play a key role in the strategic planning for all clinical programs as well as the growth and development of this new, but important function of the company.
  • You will provide specific functional expertise to enhance innovation and efficiency in Cogent's drug development programs.
  • As part of the Development leadership team, you will be responsible for statistical consulting, strategic advice and operational execution in drug developments up to submissions and approvals as well as successful reimbursement applications.


What You Will Bring:

  • The preferred candidate will have excellent statistical knowledge with the ability to apply this to scientific and clinical problems with experience in computational simulation, analysis of biomarkers, analysis of clinical imaging results, statistical methodologies, theories and analysis including adaptive designs.
  • The preferred candidate will have a proven ability to manage multiple complex projects with a track record of influencing external environment through contributions to scholarship, working parties etc., as evidenced by committee membership, presentations and publications with demonstrated scientific productivity in advancing the state-of-the-art in applied statistical methodologies.
  • Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators.
  • The candidate must have experience within a team environment, and have good leadership and managerial skills, collaborative and negotiation skills and demonstrate self-motivation.
  • Deep understanding of regulatory guidance and guidelines, as well as general knowledge of industry best practices and standards.
  • Expert knowledge in Health Authority interactions and submission strategies.
  • Prior experience with IND/BLA/NDA/MAA submissions.
  • Experience in writing technical and management documents, reports and presentations
  • A minimum of 15+ years of experience in applying statistics in a biopharmaceutical industry
  • PhD in Statistics or related discipline, MS in Statistics or related discipline

Additional Information

Our Locations

Cambridge, MA: Our Boston office is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

Boulder, CO: We are in the process of building a second location in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location, which will serve as the future home of Cogent's discovery research organization.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), unlimited time-off, a 401(k) plan, and commuter/parking benefits.

  • Cogent is an equal opportunity employer
  • Note to agencies - we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals

Keywords: Cogent Biosciences, Inc., Cambridge , Senior Director, Biostatistics, Other , Cambridge, Massachusetts

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