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
legacy for over a century
. 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.
Early Development Statistics (EDS), within Biostatistics and Research Decision Sciences (BARDS), is a department of approximately 75 statisticians providing specialized statistical support in the discovery, preclinical, non-clinical (manufacturing), translational, early phase clinical, and product lifecycle management areas of Merck Research Laboratories (MRL). Within EDS, a group of approximately 20 statisticians work on projects in the clinical pharmacology and experimental medicine (CPEM) arenas.
Reporting to the Associate Vice President (AVP) and Head of Early Development Statistics (EDS) in BARDS, the incumbent will provide statistical oversight of the CPEM statistics group. The incumbent will have at least 5 direct reports, including two Director-level managers. This position requires broad knowledge of all stages of clinical drug development and expertise in relevant areas of biostatistics to ensure that sound scientific and business principles are incorporated in the support of CPEM projects. To accomplish the above, the incumbent must have knowledge and experience in the supervision and coordination of biostatisticians in support of research design, analysis, reporting and interpretation of clinical areas across multiple therapeutic areas.
Primary Role and Activities:
Report to Associate Vice President and Head of EDS-BARDS.
Member of the EDS Leadership Team.
Sustain a high performing team supporting clinical pharmacology and experimental medicine projects.
Promote the development/application of innovative statistical methods for early phase clinical trials, including proof of biology and mechanism of action studies, as well as biomarker development/validation projects.
Represent EDS on all statistical matters involving regulatory agency aspects of CPEM projects.
Activity in the broader statistical/scientific community to enhance the objectives and representation of EDS-BARDS.
MS in statistics with at least 14 years relevant experience
PhD in statistics with at least 12 years relevant experience
Excellent oral and written communication skills are necessary.
Must have experience in collaborating with discovery and clinical research scientists
Record of functioning effectively in a cross-disciplinary team environment.
Experience managing a group of at least 5 people
A record of relevant publications/presentations, professional service and familiarity with relevant emerging trends in the pharmaceutical industry (e.g., precision medicine, digital R&D) is desirable.
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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