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Head of Biostatistics

2 months ago

New York, New York, United States nitruc Full time

Position: Director of Biostatistics

Compensation and Benefits:

20 Days of Paid Time Off (PTO)

1 Week allocated for mental health or sick leave

1 Week for Christmas-New Year’s holiday (company closure)

Competitive Base Salary with Performance-Based Bonuses

Comprehensive Medical Coverage fully paid for the employee

401K Retirement Plan

Opportunities for Professional Development and Training

Flexible and Hybrid Work Arrangements

Pet-Friendly Workplace

Key Responsibilities:

This role will play a vital part in the clinical program and departmental initiatives by collaborating closely with the clinical study team, which includes the medical director, clinical trial management, data management, and other clinical study personnel.

The Director of Biostatistics will supervise outsourced activities and deliverables from biostatistics and programming functions, ensuring timely execution and high-quality deliverables that align with the study plan.

The position will provide statistical and programming expertise in the development of clinical study designs, data analysis, data interpretation, graphical outputs, and contributions to clinical publications and regulatory submissions.

  • Work in partnership with the clinical development team to design clinical trials, ensuring appropriate application of statistical principles.
  • Act as the Biostatistics representative in global Health Authority interactions.
  • Oversee randomization plans as necessary.
  • Coordinate with data management and clinical operations to ensure alignment of statistical analysis plans with data collection procedures.
  • Facilitate and engage in cross-functional reviews of outsourced statistical deliverables, including statistical analysis plans and dataset specifications.
  • Provide rigorous statistical input and review for clinical protocols, statistical results interpretation, and scientific publications.
  • Collaborate with stakeholders to define business questions, requirements, timelines, objectives, and success criteria.
  • Develop strategies to address inquiries from health authorities regarding biostatistics.
  • Offer programming support across development to deliver summarized analyses for publications and scientific meetings.
  • Maintain and update in-house programming code.

Qualifications:

  • Familiarity with GCP, ICH, and FDA regulations is essential.
  • A Master’s degree in Statistics/Biostatistics with over 7 years of relevant experience is required.
  • Proficiency in R programming is mandatory.
  • Experience with SAS is preferred.
  • Experience in the oncology therapeutic area is required.
  • Prior experience supporting BLA or NDA filings and representing biostatistics in Health Authority interactions is necessary.
  • Able to analyze relevant data and quickly formulate an analysis plan to address key business questions.
  • Understanding of advanced statistics, including regression, time-series forecasting, clustering, and exploratory data analysis methodologies.
  • Experience with clinical database software and data structures, particularly Medidata RAVE.
  • Knowledge of CDISC standards and validation processes is required.