Job Description
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
Responsibilities:
- Supervises a group of statisticians in Late Development Statistics.
- Provides biostatistical and operational leadership to a team of statisticians in developing and coordinating statistical activities supporting drug/vaccine projects.
- Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our Company's Research Laboratories Scientists in long-range project planning, providing guidance to others in the statistical support for clinical drug/vaccine projects.
- Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- This position may serve as a statistical lead in project teams.
The incumbent may initially work in a specific disease area, such as oncology, including hematology.
Primary activities:
- Directs the scientific and technical development of statisticians. Encourages staff to conduct statistical research and publish/present scientific findings/methodologies. Mentors and guides junior staff in functional activities.
- Performs managerial, administrative duties including coaching, performance evaluation, expense report approval consistent with grant of authority.
- Directs recruiting effort to hire qualified statisticians.
- Directs biostatistical support required for assigned projects.
- Serves as lead statistician in cross-functional teams for the strategic planning and execution for product development and worldwide regulatory submissions.
- Lead a team of statisticians and the statistical programmers to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
- Represent statistics in meetings with management in strategic planning of projects.
- Represent statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.
- Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound and meet worldwide regulatory and marketing needs.
- Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and submission documents to ensure accuracy of the statistical content.
- Provides effective and efficient statistical oversight and ensures consistency of methodology.
- Coordinates statistical project assignments and resource allocation with other managers.
- Identifies needs for new statistical techniques.
- Involved in research activities for innovative statistical methods and applications in clinical trial development.
Education and Minimum Requirement:
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.
Required Skills and Experience:
- Prior supervisory and project management experiences are necessary.
- Solid knowledge of statistical analysis methodologies, clinical trial designs, and statistical and data processing software e.g. SAS and/or R.
- Solid knowledge of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- Excellent oral and written communication skills.
- Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development.
Preferred Skills and Experience:
- Publications in peer reviewed statistical/medical journals.
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Job Posting End Date: 11/4/2024
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