Director of Biostatistics

Role Overview

• Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence.
• Support is the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represent the Biostatistics function for cross-functional and intra-departmental teams or working groups.
• Functions as the lead statistician for assigned clinical projects.
• Performs management of in-house and/or outsourced biostatistical activities.
• May engage with regulatory authorities on compound/indication level discussions.
• Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed.
• Create programs for data management activities, compliant analysis datasets, and statistical analysis of the clinical trial data.
• Prepare the statistical section of clinical trial reports and presentations of the results to the team.
• Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development.
• Presenting interim trial data to Data Monitoring Committees (DMCs).
• Writing statistical reports and memos with minimal guidance.
• Programming complex datasets.
• Leading or supporting complex analyses, including efficacy and futility interim analyses for DMCs.
• Supports the preparation and documentation of statistical analyses to enable management to write and support trial reports and publications.
• Helps ensure that new and revised statistical standards, tests, and processes are implemented for increased accuracy and efficiency.
• Reviewing statements of work, proposals, and budgets.
• Managing multiple projects and a majority of own workload.
• Perform such other duties as may be assigned from time to time.

Requirements

• Master's Degree in statistics, biostatistics or a closely related field; PhD preferred
• 7+ years clinical trials experience
• Experience with rare disease and NDA/BLA submission preferred
• Strong knowledge of statistical software packages including SAS and other applications such as R, and SQL
• Strong knowledge of therapeutic area and acute care/hospital trial settings preferred
• Demonstrates strong leadership and management skills
• Ability to write and articulate clearly
• Strong sense of urgency and commitment to excellence in the successful achievement of defined project objectives
• Ability to prioritize workload to meet multiple project timelines
• Excellent planning and organization skills
• Excellent problem-solving abilities
• Ability to function independently and exercise judgment and decision-making skills

Tech Stack

• SQL