Merck Prin. Scientist, Biostatistics in West Point, Pennsylvania

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.

Major responsibilities for this position are as follows:

  • Recognized as a scientific expert in the department. Leverages functional area expertise to support pipeline programs in the quantitative aspects of study design.

· Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in CMC Statistics.

· Interacts with Merck Research Laboratories analytical, formulation and process development groups, Regulatory, Statistical Programming, Data Management, and with various Merck Manufacturing Division functional areas in designing and analyzing CMC-related studies, and in coordinating other statistical activities for drug/vaccine projects.

· Will typically serve as a statistical lead in project teams.

· May oversee the work of other statisticians.

· Responsible for supporting scientific projects or protocols.

· Independently balances activities for multiple projects.

· Represents function in cross-functional project teams; establishes collaborations /interactions with colleagues outside the department.

· Provides contribution to the successful completion of work critical to achieving department or project/ program goals; impacts therapeutic area decisions and direction.

· Participates in professional societies, technical associations and national standards committees.

Primary activities:

· Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development

· Is involved in product development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory needs.

· Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of CMC-related studies, proposes solutions and carries them out.

· Contributes to individual protocols and develops data analysis plans and independently determines appropriate statistical methodology for analysis.

· Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.

· Analyzes data and interprets results from CMC-related studies to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.

· Prepares oral and written reports to effectively communicate results to the project team, Merck Management, regulatory agencies, or individual scientists.

· Provides responses to queries relating to study design, analysis, and interpretation posed by scientists, Contract Research Organizations, and/or regulatory agencies.

· May participate with management in discussions with corresponding scientific personnel at regulatory agencies concerning proposed or ongoing studies.

· Involved in research activities for innovative statistical methods and applications.

· Provide scientific mentorship and coaching and give feedback on employment development plans and performance reviews to the managers of the scientists that they oversee.

· Provides strategic scientific oversight and mentorship to other quantitative scientists and project teams.

· Produces high quality and timely results that contribute to pipeline projects and inform team decisions including regulatory interactions.

· Will typically serve in the lead role on the quantitative aspects of particular studies and scientific investigations.

· Acts as a technical resource within the department and in their area of focus.

· Scientists who are overseeing the work of other scientists have the added responsibility of assisting in the design, planning, execution and/or interpretation of experiments. These Scientists provide scientific mentorship and coaching and give feedback on employment development plans and performance reviews to the managers of the scientists that they oversee.

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Education Minimum Requirement: Ph.D (preferred ) or MS in Biostatistics or Statistics

Required Experience and Skills ** : PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 3 years relevant work experience, or Masters with a minimum of 6 years relevant work experience.

· Solid knowledge of statistical analysis methodologies and experimental design.

· Familiar with nonlinear regression, mixed models, variance component analysis, DOE, stability study design & analysis, (bio)assay validation, statistical programming (e.g., SAS, S-plus, R) and general statistical methodology.

· Working knowledge of statistical and data processing software e.g. SAS and/or R.

· Solid understanding of ICH, Regulatory and Pharmacopeial requirements as they pertain to CMC sections of INDs, BLAs or other similar regulatory submissions.

· Strong oral and written communication skills. Able to function effectively in a team environment.

· Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

· Good collaborative and communication skills.

Preferred Experience and Skills:

· Publications in peer reviewed statistical/medical journals.

· Good understanding of pharmaceutical and biological developmental process.

· Basic understanding of chemistry, biology, virology and other related sciences.

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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com .

Search Firm Representatives Please Read Carefully:

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Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at http://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Biostatistics

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Other Locations: NA-US-PA-West Point

Title: Prin. Scientist, Biostatistics

Primary Location: NA-US-NJ-Kenilworth

Requisition ID: BIO005157