Director/Sr. Director, Biostatistics
Invivyd
2 days ago
Remote friendly (New Haven, CT)
United States
$184,000 - $293,000 USD yearly
Clinical Research and Development
Responsibilities:
- Apply statistical expertise to ensure innovative clinical trial designs, analysis methods, and data displays; deliver high-quality writing and supervise statistical analysis plans
- Use advanced statistical techniques to analyze clinical study data
- Perform clinical trial simulations to optimize clinical trial designs
- Ensure scientific integrity of statistical methodology applied to clinical trials
- Provide input to development programs, including worldwide filing strategies, study design, analytic methods, and endpoints meeting regulatory and scientific requirements
- Collaborate with clinical data management, clinical research, global drug safety, regulatory, and project management
- Present and represent biostatistics to therapeutic leads, senior management, external collaborators, and at FDA and medical/statistical meetings
- Provide statistical direction and technical oversight for projects requiring statistical input
- Support presentation/publication of clinical trial results and contribute to statistical advances; present at scientific conferences
- Clarify statistical deliverables and timelines for analysis and reporting, and ensure they are met
- Use methods for missing data, multiple comparisons/endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics
Requirements:
- PhD in statistics/biostatistics or equivalent with 10+ years biopharmaceutical industry experience required (MS with 14+ years extensive industry/leadership experience may be considered)
- Scientific programming experience with SAS or R
- Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions; NDA/MAA experience required
- Ability to travel to New Haven 1x a month
Highly Preferred:
- Experience providing statistical support for medical affairs and market access activities
Compensation:
- Director base pay range: $184,000–$245,000
- Senior Director base pay range: $220,000–$293,000
- Eligible for annual short-term incentive (e.g., bonus/sales incentive) and annual long-term incentive (e.g., equity)
- Apply statistical expertise to ensure innovative clinical trial designs, analysis methods, and data displays; deliver high-quality writing and supervise statistical analysis plans
- Use advanced statistical techniques to analyze clinical study data
- Perform clinical trial simulations to optimize clinical trial designs
- Ensure scientific integrity of statistical methodology applied to clinical trials
- Provide input to development programs, including worldwide filing strategies, study design, analytic methods, and endpoints meeting regulatory and scientific requirements
- Collaborate with clinical data management, clinical research, global drug safety, regulatory, and project management
- Present and represent biostatistics to therapeutic leads, senior management, external collaborators, and at FDA and medical/statistical meetings
- Provide statistical direction and technical oversight for projects requiring statistical input
- Support presentation/publication of clinical trial results and contribute to statistical advances; present at scientific conferences
- Clarify statistical deliverables and timelines for analysis and reporting, and ensure they are met
- Use methods for missing data, multiple comparisons/endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics
Requirements:
- PhD in statistics/biostatistics or equivalent with 10+ years biopharmaceutical industry experience required (MS with 14+ years extensive industry/leadership experience may be considered)
- Scientific programming experience with SAS or R
- Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions; NDA/MAA experience required
- Ability to travel to New Haven 1x a month
Highly Preferred:
- Experience providing statistical support for medical affairs and market access activities
Compensation:
- Director base pay range: $184,000–$245,000
- Senior Director base pay range: $220,000–$293,000
- Eligible for annual short-term incentive (e.g., bonus/sales incentive) and annual long-term incentive (e.g., equity)