Location: Northeast Preferred

The Director of Biostatistics is a proven thought leader in statistical science with strong technical skills and a recent NDA/BLA track record provides direction on clinical development plans, protocols and analysis, reviews clinical study reports and regulatory submission materials, and ensures that standard procedures are followed within projects. This person is responsible for implementing consistent statistical conduct for the department and liaising with clinical research personnel to identify and meet their needs for statistical support. This person also interacts with the head of statistical programming and data management to synchronize prioritization of projects and, in some cases, represent biostatistics in meetings with executive committees, commercial, regulatory agencies, and external development partners in the absence of the Head of Biometrics.

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)
• 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
• Ability to travel to New Haven 1x a month

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