Role Summary
Director of Biostatistics, remote position. Reports to the Executive Director of Biostatistics and focuses on contributing to multiple studies, analyzing and reporting on clinical studies. Oversees statistical programming and deliverables to ensure quality assurance and control of analyses, writes methods and analysis descriptions in formal reports, communicates with collaborators, and maintains confidential project materials.
Responsibilities
- 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 for the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represents the Biostatistics function for cross-functional and intra-departmental teams or working groups.
- Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed.
- Create or validate SAS 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.
- Writing statistical reports and memos with minimal guidance.
- Validating complex datasets or summary tables.
- Prepares and documents facts to enable management to write and support trial reports and publications.
- Other duties as assigned.
Qualifications
- Master's Degree in statistics, biostatistics or a closely related field; PhD preferred.
- Ten plus (10+) years clinical trials experience with at least three (3) years in oncology clinical trials.
- Experience with solid tumor oncology and NDA/BLA submission preferred.
- Strong knowledge of statistical software packages including SAS and R. Other statistical analysis and reporting applications such as Splus and SQL are plus.
- 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 delivery timelines.
- Excellent planning and organization skills.
- Excellent problem-solving abilities.
- Ability to function independently and exercise judgment and decision-making skills.
- Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization.
- Flexible and willing to learn; adapting to business and site needs in a dynamic environment.
- Maintain a positive, approachable and professional attitude.