Head of Biostatistics

1 week ago

New York, New York, United States nitruc Full time

Position: Director of Biostatistics

Benefits Overview:

20 Days of Paid Time Off (PTO)

1 Week designated for mental health and sick leave

1 Week holiday closure during Christmas to New Year's

Competitive Base Salary complemented by Performance-based Bonuses

Comprehensive Medical Coverage fully funded 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 driving departmental initiatives through collaboration with the clinical study team, which includes the medical director, clinical trial management, data management, and other clinical personnel.

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

The position demands statistical and programming proficiency to aid in the formulation of clinical study designs, conducting data analyses, interpreting results, and contributing to scientific publications and regulatory submissions.

  • Engage with the clinical development team to design clinical trials that effectively apply statistical principles.
  • Act as the Biostatistics representative during global Health Authority interactions.
  • Oversee randomization plans as necessary.
  • Coordinate with data management and clinical operations to ensure alignment between statistical analysis plans and data collection methodologies.
  • Facilitate cross-functional reviews of outsourced statistical deliverables, including statistical analysis plans and dataset specifications.
  • Provide rigorous statistical insights and reviews for clinical protocols, statistical results interpretation, and scientific publications.
  • Collaborate with stakeholders to clarify business inquiries, requirements, timelines, objectives, and success metrics.
  • Develop strategies to effectively address inquiries from health authorities regarding biostatistics.
  • Offer programming support across development to deliver summarized analyses for publications and scientific meetings.
  • Maintain and enhance in-house programming code.

Qualifications:

  • In-depth knowledge of GCP, ICH, and FDA regulations is essential.
  • A Master's degree in Statistics or Biostatistics with a minimum of 7 years of relevant experience is required.
  • Proficiency in R programming is mandatory.
  • Experience with SAS is preferred.
  • Demonstrated experience in the oncology therapeutic area is necessary.
  • Prior involvement in supporting BLA or NDA submissions and representing biostatistics in Health Authority interactions is required.
  • Adept at analyzing relevant data and formulating effective analysis plans to address critical business questions.
  • Strong understanding of clinical or advanced statistical methodologies, including regression, time-series analysis, clustering, and exploratory data analysis.
  • Experience with clinical database software and data structures, particularly Medidata RAVE, is advantageous.
  • Familiarity with CDISC standards and validation processes is required.

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