Director, Biostatistics Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
- Manages and mentors staff of 5-7 statisticians in Early Clinical Development Statistics (ECDS) who work on collaborative teams that support Discovery Medicine and Translational Biomarkers across multiple therapeutic areas, and/or Early Development Oncology projects.
- Interacts with Basic Research, Clinical, Regulatory, Statistical Programming, Data Management, and/or other Merck Research Laboratories Scientists (and their management, if needed) in project planning and execution.
- Conducts project work and applied research, as needed.
- Assigns project work to supervised statisticians, and mentors/guides them in functional activities
- Serves as protocol/project/EDT statistician for selected projects, as needed
- Ensures the statistical designs and analysis methods utilized in clinical studies are scientifically sound
- Performs comprehensive reviews of protocols, statistical analysis plans, clinical study reports, and related documents to ensure accuracy of the statistical content
- Represents statistics in meetings with management in strategic planning of projects
- Directs the scientific, technical and professional development of statisticians
- Encourages staff to conduct statistical research and participate in departmental/external activities
- Performs administrative duties including coaching, performance evaluation, expense report approval consistent with grant of authority
- 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.
- Prior experience as a manager of at least 3 staff is required.
- Solid knowledge of statistical analysis methodologies, clinical trial designs, and statistical and data processing software (SAS and/or R).
- Broad knowledge of clinical development from phase I to V (end-to-end).
- Solid knowledge of clinical database systems.
- Excellent oral and written communication skills.
- Prior experience with clinical biomarker development, qualification and validation.
- Publications in peer reviewed statistical/medical journals.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job Title:Dir, Biostatistics
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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