Associate Director of Biostatistics

3 days ago

Watertown, Massachusetts, United States C4 Therapeutics Inc Full time
About C4 Therapeutics

C4 Therapeutics is a clinical-stage biopharmaceutical company dedicated to harnessing the power of targeted protein degradation science to create innovative medicines that transform patients' lives. Our TORPEDO platform enables us to design and optimize small-molecule medicines to address difficult-to-treat diseases, offering the potential to overcome drug resistance and improve patient outcomes.

Job Summary

We are seeking an experienced Associate Director of Biostatistics to lead statistical aspects of clinical development projects. This role will collaborate with clinicians, clinical scientists, and cross-functional teams to plan, conduct, and analyze clinical studies in all phases. The successful candidate will be responsible for leading statistical strategies, executing study designs, and providing statistical input to regulatory submissions and publications.

Your Role

  • Develop and execute statistical strategies for clinical studies, including study design, statistical analysis, and study results presentation and interpretation.
  • Provide statistical leadership to cross-functional activities and collaborate with colleagues to make progress on assigned projects.
  • Contribute to study documents, such as statistical sections of study protocols, statistical analysis plans, and CRFs.
  • Collaborate with statistical programmers on summary and analysis of study data.
  • Plan and execute ad-hoc and exploratory analyses to support business needs.
  • Manage CRO statistical and programming support.
  • Oversee and QC essential documents / data provided by vendors.
  • Provide statistical support to ensure study data quality.
  • Represent biostatistics at internal and external meetings.
  • Contribute to department and company process improvement initiatives and SOPs.
  • Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs.

Your Background

  • PhD in Statistics, Mathematics, or related fields with 5+ years of industry experience in clinical trials, or MS with 7+ years of experience.
  • Experience in oncology drug development is required.
  • Demonstrated technical knowledge of statistical methodology and proven ability to appropriately apply it in trial design, data analysis, and result interpretation to support clinical development.
  • Strong hands-on skills in statistical analyses, modeling, and trial simulation.
  • Proficiency in programming languages such as SAS and R.
  • Experience working with SDTM, ADaM, eSUB, and CDISC requirements.
  • Experience with regulatory submissions, including NDAs and BLAs, is preferred.
  • Experience with biomarker analysis is preferred.
  • Experience overseeing CRO and consultants to deliver high-quality outputs.
  • Ability to be flexible and adapt quickly to the changing needs of the organization.
  • Strong communication skills and demonstrated ability to develop relationships within the organization to achieve business goals.
  • Demonstrated technical leadership for assigned activities and clinical projects.
  • Passionate about quantitative decision making.
  • Strong communication skills to lead team discussions.
  • Able to effectively communicate verbally and in writing in English.
  • Willing and able to work in a fast-paced biotech environment.

C4 Therapeutics is an Equal Opportunity Employer.

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