Invivyd is seeking a Director of Biostatistics to provide statistical direction and technical oversight for projects requiring statistical input, ensuring the scientific integrity and innovative design of clinical trials, and supporting regulatory submissions for novel antibody candidates aimed at protecting immunocompromised individuals from severe viral infectious diseases.
Requirements
- Scientific programming experience with SAS or R
- Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required)
- Utilizes knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics
Responsibilities
- Applies statistical expertise to ensure innovative clinical trial designs, analysis methods and data displays; accountable to deliver high quality writing and supervision of statistical analysis plans
- Uses advanced statistical techniques to analyze clinical study data
- Performs clinical trial simulations to optimize clinical trial designs
- Ensures scientific integrity of the statistical methodology applied to clinical trials
- Provides input to development programs including filing strategies worldwide, study design, analytic methods, and endpoints that meet both regulatory and scientific requirements
- Makes presentations and may represent biostatistics to therapeutic leads, senior management, external collaborators, FDA meetings and medical and statistical meetings
- Provides statistical direction and technical oversight for projects requiring statistical input
Other
- PhD in statistics, biostatistics or equivalent area with 10+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (14+ years) can be considered
- Ability to travel to New Haven 1x a month
- Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used
- Experience in providing statistical support for medical affairs and market access activities is highly preferred
- Collaborates with other functional areas within the company (clinical data management, clinical research, global drug safety, regulatory and project management)
