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Director, Biostatistics

Oakland, California or Cambridge, Massachusetts

Company Overview

At Aditum Bio our mission is to provide access to medicines to patients in need.  Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies and advances them into Phase 1 and Phase 2 clinical studies to enable proof of concept.   The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

Position Summary

The Director, Biostatistics will oversee the design, analysis, and interpretation of data for assigned clinical programs. The Director, Biostatistics will be responsible for statistical leadership and guidance in novel therapeutics development to ensure statistical methodologies are sound, regulatory compliant, and aligned with assigned portfolio company’s goals while collaborating effectively with clinical and scientific stakeholders.

Position Responsibilities

  • Lead statistical design, analysis, and reporting for clinical trials, ensuring alignment with regulatory guidelines.
  • Collaborate with Clinical Development and other cross-functions in defining the drug development questions, the endpoints required, and the associated statistical approach.  
  • Develop statistical methodologies for clinical trial design (e.g., sample size determination, power analysis, randomization) and ensure rigorous analysis of study results.
  • Collaborate with cross-functional teams (clinical operations, regulatory and nonclinical) to guide decision-making based on statistical evidence.
  • Work with program teams on clinical and regulatory strategies and to lead statistical discussions in regulatory agency interactions including meetings.
  • Oversee clinical trial statistical deliverables including but not limited to Randomization, SAP, TLFs outsourced to CROs.
  • Ensure data integrity, quality, and reproducibility in statistical analyses, and contribute to the interpretation and presentation of results.
  • Stay up to date on new statistical methodologies and best practices in the field of biostatistics.
  • Review and evaluate external vendors and consultants for statistical services and support as needed.
  • Contribute to preclinical studies as needed.

 Qualifications

  • Advanced degree in Biostatistics, Statistics, or a related field.
  • At least 8 years of biopharma experience, with a track record in clinical trial design and analysis, ideally in agile biotech environments.
  • Experience with early phase development and adaptive designs preferred.
  • Experience in Neuroscience or Immunology therapeutics area preferred.
  • Experience with statistical software (e.g., SAS, R, Stata, or equivalent) and strong programming skills.
  • Demonstrated command of regulatory guidelines and requirements (e.g., FDA, ICH) and experience in regulatory agency interactions strongly preferred.
  • Strong communication skills with the ability to communicate complex statistical concepts to non-statistical stakeholders.
  • Ability to collaborate effectively with cross-functional teams in a fast-paced, dynamic environment.
  • Attention to detail and ability to work under tight deadlines – results oriented.

The range for this full-time position is $225,000 - $250,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.

 

We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

 

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