Director, Biostatistics
Tango Therapeutics
8 days ago
Remote friendly (Boston, MA)
United States
$191,200 - $286,800 USD yearly
Clinical Research and Development
Your Role:
- Serve as a biostatistics expert for clinical programs
- Provide strategic input to optimize trial designs in early-phase dose escalation and late-phase registrational studies
- Collaborate with internal and external CRO teams to plan and execute statistical deliverables
- Conduct statistical modeling to support robust/efficient designs and address statistical issues
- Contribute to clinical protocol development (author/review Statistics section and apply statistical principles to other sections)
- Author/review statistical analysis plans and oversee creation of tables, figures, listings, and related deliverables
- Review eCRF designs to ensure data collection supports statistical analyses
- Provide statistical input for clinical documents
- Perform QC/QA of statistical deliverables, including validation of key results
- Perform ad hoc statistical analyses as needed
- Contribute to clinical study reports (statistical methods, interpretation)
- Support IND/NDA/MAA (or other regulatory) submissions, including thorough review of required components
- Address statistical questions/comments from FDA and other agencies/IRB/ECs
- Support publications (manuscripts, posters, oral presentations)
- Lead standardization and process improvement for Biostatistics (templates/standards)
- Represent Tango on statistical issues in external meetings
- Support inspection readiness as needed
- Maintain advanced statistical methodology/advanced trial design competencies (oncology)
What You Bring:
- PhD in statistics (or related); or MS with appropriate relevant experience
- At least 10 years’ pharmaceutical/biotech industry experience
- Oncology experience required
- Clinical trial design, analysis, and reporting experience
- Experience with INDs/NDAs/MAAs or other regulatory submissions
- In-depth clinical trial statistical methods knowledge
- FDA/EMA/ICH knowledge
- Proficiency in SAS and R
- Ability to lead statistical efforts for multiple studies
- Data standards knowledge (SDTM, ADaM)
- Experience with outsourced CRO statistical services
- Independent, initiative-driven, excellent written/oral communication
Salary range: $191,200—$286,800 USD
- Serve as a biostatistics expert for clinical programs
- Provide strategic input to optimize trial designs in early-phase dose escalation and late-phase registrational studies
- Collaborate with internal and external CRO teams to plan and execute statistical deliverables
- Conduct statistical modeling to support robust/efficient designs and address statistical issues
- Contribute to clinical protocol development (author/review Statistics section and apply statistical principles to other sections)
- Author/review statistical analysis plans and oversee creation of tables, figures, listings, and related deliverables
- Review eCRF designs to ensure data collection supports statistical analyses
- Provide statistical input for clinical documents
- Perform QC/QA of statistical deliverables, including validation of key results
- Perform ad hoc statistical analyses as needed
- Contribute to clinical study reports (statistical methods, interpretation)
- Support IND/NDA/MAA (or other regulatory) submissions, including thorough review of required components
- Address statistical questions/comments from FDA and other agencies/IRB/ECs
- Support publications (manuscripts, posters, oral presentations)
- Lead standardization and process improvement for Biostatistics (templates/standards)
- Represent Tango on statistical issues in external meetings
- Support inspection readiness as needed
- Maintain advanced statistical methodology/advanced trial design competencies (oncology)
What You Bring:
- PhD in statistics (or related); or MS with appropriate relevant experience
- At least 10 years’ pharmaceutical/biotech industry experience
- Oncology experience required
- Clinical trial design, analysis, and reporting experience
- Experience with INDs/NDAs/MAAs or other regulatory submissions
- In-depth clinical trial statistical methods knowledge
- FDA/EMA/ICH knowledge
- Proficiency in SAS and R
- Ability to lead statistical efforts for multiple studies
- Data standards knowledge (SDTM, ADaM)
- Experience with outsourced CRO statistical services
- Independent, initiative-driven, excellent written/oral communication
Salary range: $191,200—$286,800 USD