Head of Biostatistics

2 weeks ago

New York, New York, United States nitruc Full time

Position: Director of Biostatistics

Benefits:

20 Days Paid Time Off

1 Week of Mental Health/Sick Leave

1 Week: Holiday Closure (Christmas to New Year)

Competitive Base Salary + Performance-Based Bonus

Comprehensive Medical Coverage Fully Paid for Employee

401K Retirement Plan

Opportunities for Professional Development and Training

Flexible Hybrid Work Environment

Pet-Friendly Workplace

Key Responsibilities:

This role is pivotal in enhancing the clinical program and supporting both departmental and cross-functional initiatives by collaborating closely with the clinical study team, which includes the medical director, clinical trial management, data management, and other personnel involved in clinical studies.

The Director of Biostatistics will oversee outsourced tasks and deliverables from biostatistics and programming teams, ensuring timely execution and high-quality deliverables in accordance with the study plan.

The incumbent will provide statistical and programming expertise essential for developing clinical study designs, conducting data analyses, interpreting data, generating graphical outputs, and contributing to clinical publications and regulatory submissions.

  • Work alongside the clinical development team to design clinical trials, ensuring the appropriate application of statistical principles.
  • Act as the Biostatistics representative in global Health Authority interactions.
  • Manage randomization plans as necessary.
  • Collaborate with data management and clinical operations to ensure alignment between statistical analysis plans and data collection methodologies.
  • Facilitate and engage in cross-functional reviews of outsourced statistical deliverables, including statistical analysis plans, TLF shells, specifications, and SDTM/ADaM datasets.
  • Provide rigorous statistical input and review for clinical protocols, interpretation of statistical results, and scientific publications.
  • Engage 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 tabular and graphic 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 a BLA or NDA filing and representing biostatistics in discussions with health authorities is necessary.
  • Able to analyze relevant data and swiftly develop an analysis plan to address key business inquiries.
  • Understanding of advanced statistics, including regression, time-series forecasting, clustering, decision trees, and exploratory data analysis methodologies.
  • Experience with clinical database software and data structures, particularly Medidata RAVE.
  • Familiarity with CDISC standards and validation processes is required.

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