Director, Biostatistics
$191,200–$286,800 year
HybridBoston, Massachusetts, United States
Job Summary
Oversee statistical activities across Tango's clinical programs, including managing outsourced deliverables to clinical CROs. Provide strategic input to optimize trial designs in early phase dose escalation and late phase registrational studies. Collaborate with internal and external teams to coordinate planning, conduct statistical modeling, and contribute to protocol development and analysis plans. Review eCRF designs, perform QC/QA of deliverables, and author statistical methods for clinical study reports. Address regulatory agency queries and support inspection readiness while leading standardization and process improvement efforts for the Biostatistics function.
Required Qualifications
- PhD in statistics or related discipline
- MS with appropriate years of directly relevant experience
- At least 10 years' experience in the pharmaceutical or biotech industry
- Oncology experience
- Experience in the design, analysis, and reporting of clinical trials
- Experience in INDs, NDAs, MAAs, or other regulatory submissions
- In-depth knowledge of statistical methods for clinical trials
- Knowledge of FDA, EMA, and ICH regulations and guidelines
- Proficient in statistical programming (SAS and R)
- Ability to lead statistical efforts for multiple studies
- Fluent in data standards, including SDTM and ADaM
- Experience in outsourced statistical services provided by CROs
- Ability to work independently and act with initiative to address issues
- Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner
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