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
- Collaborates with other functional areas within the company (clinical data management, clinical research, global drug safety, regulatory and project management)
- 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
- Supports the presentation and publication of clinical trial results and contribution to advances on statistical topics and presents at scientific conferences
- Clarifies project deliverables and timelines for statistical analysis and reporting and ensure that they are met
- Utilizes knowledge of methods for handling missing data, multiple comparisons and multiple endpoints, interim analyses, simulation techniques, adaptive designs, and bioinformatics
Requirements
- 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
- 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)
Nice to Have
- Experience in providing statistical support for medical affairs and market access activities is highly preferred
- Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used
Work Arrangement
Remote (City/Region)
Additional Information
- Ability to travel to New Haven 1x a month
