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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 designated for mental health/sick leave

1 Week: Holiday Closure during the Christmas-New Year period

Competitive Base Salary complemented by a Performance-Based Bonus

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 is pivotal in enhancing the clinical program and supporting departmental and cross-functional projects by collaborating closely with the clinical study team, which includes the medical director, clinical trial management, data management, and other clinical study professionals.

The Director of Biostatistics will supervise outsourced functions and deliverables from biostatistics and programming teams, ensuring timely execution and adherence to high-quality standards as outlined in the study plan.

The incumbent will offer statistical and programming expertise in developing clinical study designs, conducting data analyses, interpreting results, creating graphical outputs, and contributing to clinical publications and regulatory submissions.

  • Engage 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.
  • Collaborate with data management and clinical operations to ensure alignment of statistical analysis plans with data collection methods.
  • Facilitate and participate in cross-functional reviews of outsourced statistical deliverables, including statistical analysis plans and dataset specifications.
  • Provide scientifically rigorous statistical input and review of clinical protocols, as well as interpretation of statistical results and scientific publications.
  • Work with stakeholders to define business inquiries, requirements, timelines, objectives, and success criteria.
  • Develop strategies to address inquiries from health authorities regarding biostatistics.
  • Provide programming support across development to facilitate the delivery of summarized analyses for publications and scientific meetings.
  • Maintain and update in-house programming code.

Qualifications:

  • Knowledge of GCP, ICH, and FDA regulations is essential.
  • A Master's degree in Statistics/Biostatistics with a minimum of 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 involvement in supporting BLA or NDA filings and representing biostatistics in Health Authority interactions is necessary.
  • Able to analyze relevant data and swiftly develop an analysis plan to address key business questions.
  • Understanding of advanced statistical methodologies, including regression, time-series forecasting, clustering, and exploratory data analysis.
  • Experience with clinical database software and data structures, particularly Medidata RAVE.
  • Familiarity with CDISC standards and validation processes is required.