Senior Principal Scientist, Biostatistics Job
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.
This position is for a Statistician who will contribute to and lead projects aimed at identifying, developing and validating biomarkers and platforms (including genetics and gene expression) to be used as drug development tools for Merck compounds. These projects may be identified from internal and external, early and late phase clinical trials. Primary responsibilities will be to:
- Develop, coordinate, and provide statistical leadership and support for projects focused on molecular and other exploratory biomarkers.
- Mentor and guide junior statisticians supporting projects focused molecular and other exploratory biomarkers.
- Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing data from clinical trials. Coordinate all statistical activities for ongoing clinical projects. Interact with Contract Research Organizations, as appropriate.
- Serves as a statistical representative on cross-functional teams for the strategic planning and execution of product development
- Develops individual protocols and statistical analysis plans and independently determines appropriate statistical methodology for analysis.
- Contributes to the scientific and technical development of statisticians
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
- Prepares oral presentations and written reports to effectively communicate clinical trial results to the project team, Merck Management, regulatory agencies, or individual investigators.
- Consults on biomarker aspects of the clinical development strategy to meet scientific and regulatory project goals.
- Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
- Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
- Participates in database design meetings as needed, to ensure that the data evaluated are in high quality and satisfy analysis requirements.
- Collaborates with statistical programming staff to ensure all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
- Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
- Responds to queries relating to study design, analysis, and interpretation posed by clinical monitors, regulatory agencies, and/or investigators.
- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
- Conducts research activities for innovative statistical methods and applications in clinical trial development, especially related to the use of oncology and pharmacogenetic biomarkers.
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant experience, or a Master’s degree with a minimum of 12 years relevant experience.
- Strong project management skills
- Experience managing or mentoring statisticians in project-related activities
- Good understanding of worldwide regulatory requirements and clinical trial expertise from phase I to IV (end to end)
- Solid knowledge of statistical analysis methodologies and experimental design
- Solid knowledge of statistical and data processing software e.g. SAS and/or R
- Ability to work with large complex data sets
- Excellent oral and written communication skills
- Ability to function effectively both independently and in a team environment
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial association with biomarkers
- Demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution
- Ability to collaborate with scientists and work on multi-discipline teams
- A specialization and relevant job experience in oncology and/or pharmacogenetics
- An understanding of modern techniques for statistical and/or machine learning
- An understanding of the biology of disease
- Publications in peer reviewed statistical/medical journals.
- Prior experience with clinical biomarker development, qualification and validation.
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. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Employee Status: Regular
Travel: Yes, 5 % of the Time
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Company Trade Name: Merck