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.
Randomized Clinical Trial (RCT) evidence is an essential component of the benefit argument in Health Technology Assessment (HTA) Dossiers; it is critical to distinguishing the added clinical benefit and health economic utility of Merck products. The HTA Statistics group, within Biostatistics and Research Decision Sciences (BARDS), Global Clinical Development (GCD), is responsible for providing innovative statistical solutions to HTA strategies and problems, and high quality support of HTA Dossiers that align with Merck Research Laboratories (MRL) science and have impact on the market access of Merck medicines.
Reporting to the Senior Vice President and Head of BARDS, the incumbent has centralized responsibility and decision making authority for all biostatistics activities in support of HTA Dossiers and submissions. This requires a broad, comprehensive, in-depth knowledge of biostatistics to ensure that sound scientific principles are incorporated into support of HTA strategies and analyses. The incumbent will be the BARDS expert on the biostatistics support of HTA strategies and Dossier submissions.
- Build and maintain a high performing Statistics organization to support all HTA activities related to clinical evidence
- Promote the novel application of existing statistics methods for HTA submissions (e.g. indirect treatment comparisons, (network) meta analyses, systematic literature reviews and evidence synthesis, adjustments for treatment switching in oncology trials)
- Foster an effective collaboration with BARDS-HTA Statistics and MRL Center for Observational and Real World Evidence (CORE)
- Collaborate with BARDS Late Development Statistics (LDS) function to ensure alignment between a product's regulatory submissions and the product's HTA dossiers/reimbursement submissions
- Collaborate with the BARDS Statistical Programming (SP) staff dedicated to HTA to ensure that all deliverables meet analysis requirements, internal standard operating procedures and HTA submission requirements
- Proactively interact with HTA agencies worldwide to resolve statistical issues associated with HTA requests and submissions
- Stimulate the scientific and technical development of BARDS HTA statisticians relative to HTA methodology.
- Maintain external contacts that further the objectives and reputation of the BARDS HTA Statistics group's support of HTA submissions (e.g. EUnetHTA).
- Work closely with MRL-IT to ensure a computing platform that meets the needs for the HTA Statistics organization
- Leverage BARDS infrastructure and technical functions in support of HTA activities
- Master of Science in Statistics required.
- Doctorate in Statistics is preferred.
Required Skills and Experience:
- A minimum of 10 years of experience in statistical design and analysis with a working knowledge of computing and data management environments.
- A minimum of 5 years of management experience with biostatisticians in a major professional environment.
- Experience in collaborating with clinical scientists.
- Able to function effectively in a team environment.
- Excellent oral and written communication skills.
- Creativity and innovations are expected.
Preferred Skills and Experience:
- Solid project management skills
- Ability to work effectively with personnel with different functional backgrounds (e.g. clinical and observational/outcomes research, health economics, market access).
- Understanding of the HTA environment and the importance of market access activities.
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