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Head of Biostatistics
2 months ago
Position: Director of Biostatistics
Compensation and Benefits:
20 Days of Paid Time Off (PTO)
1 Week allocated for mental health/sick leave
1 Week: Holiday closure during Christmas-New Year
Competitive Base Salary plus Performance-based Bonuses
Comprehensive Medical Coverage fully paid for the employee
Retirement Savings Plan (401K)
Opportunities for Professional Development and Training
Flexible Work Arrangements including Hybrid options
Pet-friendly Workplace
Key Responsibilities:
This role is essential 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 tasks and deliverables from biostatistics and programming teams, ensuring timely execution and adherence to high-quality standards as per the study plan.
The incumbent will offer statistical and programming expertise in 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.
- Oversee randomization plans when applicable.
- Collaborate with data management and clinical operations to ensure alignment of statistical analysis plans with data collection methods.
- Facilitate cross-functional reviews of outsourced statistical deliverables, including statistical analysis plans, TLF shells, and datasets.
- Provide rigorous statistical input and review of clinical protocols, statistical results interpretation, and scientific publications.
- Engage with stakeholders to define business inquiries, 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:
- Knowledge of 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 necessary.
- Prior involvement in supporting BLA or NDA filings and representing biostatistics in health authority interactions is required.
- Able to analyze relevant data and swiftly formulate an analysis plan to address key business questions.
- Understanding of advanced statistical methods such as regression, time-series forecasting, clustering, decision trees, and exploratory data analysis.
- Experience with clinical database software and data structures, particularly Medidata RAVE.
- Familiarity with CDISC standards and validation processes is required.
