Senior Director, Biostatistics

Oncology Biotech
MA, United States
Full-time

We are pioneering the development of breakthrough cancer therapies by exploiting synthetic lethality. Our approach to targeted oncology is unique, collaborative, and driven by data.

Joining us, means working alongside some of the brightest minds in biotech, where you can make a profound impact on patients’ lives.

We invite you to be part of our dynamic team and contribute to life-saving innovations in cancer care.

Position Summary

We are seeking an experienced, innovative, and results-oriented Senior Director of Biostatistics to lead our biostatistics strategy and support clinical trial design and execution.

This role is essential in guiding statistical analysis and data interpretation across clinical programs, collaborating with cross-functional teams to ensure rigor in data quality and strategic decision-making.

You will be a key partner in advancing the company’s mission to bring transformative cancer treatments to patients.

Key Responsibilities

  • Cross-Functional Leader working with Clinical, Medical, and Regulatory Functions
  • Lead the biostatistics pivotal compounds, overseeing all statistical aspects of clinical development programs, from early-phase to registration trials.
  • Develop statistical strategies for clinical studies, including design, sample size estimation, endpoint selection, and statistical analysis plans.
  • Collaborate with clinical development, regulatory, data management, and other stakeholders to ensure robust statistical methodologies are applied.
  • Provide strategic input into regulatory submissions, responses to regulatory agencies, and publication activities.
  • Mentor a team of statisticians fostering a collaborative and growth-oriented environment.
  • Ensure compliance with regulatory guidelines (FDA, EMA, ICH) and company internal standards.
  • Stay current with advancements in biostatistics and clinical trial methodologies, particularly in oncology and precision medicine.

Qualifications

  • Ph.D. or Master’s degree in Biostatistics or Statistics
  • 10+ years of industry experience within Oncology Biotech or pharmaceutical companies (CRO experience does not meet the qualifications)
  • Phase II-III Oncology Sponsor Experience
  • Proven expertise in clinical trial design, statistical analysis, and regulatory submissions.
  • Excellent communication and leadership skills, with a track record of cross-functional collaboration.
  • Strategic mindset with a proactive approach to solving complex statistical challenges.

Why Join Us?

  • Impact : Make a difference in the lives of cancer patients with cutting-edge research and development.
  • Growth : We support and invest in your career development through continuous learning and mentorship.
  • Culture : Experience a collaborative, inclusive, and innovative environment where each team member’s contributions are valued.

Please submit your resume in order to for more details. They pay very well with fun company perks which employees love and fosters a fun collaborative environment.

5 hours ago
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