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. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- To apply solid knowledge of statistical methodology and experimental design to plan laboratory and field animal studies for biologic and pharmaceutical veterinary compounds/antigens/bacteria/viruses for Research and Development, Discovery, Pre-Clinical, Clinical Research, and Drug Metabolism
- To support conduct of clinical trials by providing statistical input to study protocols, producing randomization codes, addressing data collection issues, and evaluating protocol amendments and deviations for effect on data analysis and interpretation
- To co-develop standardized Case Report Forms (CRF) with Clinical, and develop/maintain databases to retain clinical data by following good Data Management practices.
- To statistically analyze clinical, laboratory, or production data, and prepare reports that easily and concisely present the reader with clear conclusions.
- To collaborate on R&D and Clinical study reports, and provide statistical review of externally generated reports
- To support submission of study results to appropriate Regulatory Agencies including, but not limited to, United States Department of Agriculture (USDA), United States Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM), European Medicines Agency (EMA) Committee for Medicinal Products for Veterinary use (CVMP), and United States Environmental Protection Agency (EPA).
- To interact with Regulatory, Legal or other authorities on statistical issues related to product development, registration, investigations, patents
- To support Production, Quality Control, Analytical Testing, Process Control, Process Optimization, with statistical expertise, when possible
- To support Commercial Operations and Marketing/Sales with clinical designs during development to achieve the desired product label, and with post-marketing studies, when possible
- To collaborate with, Veterinarians, Project Managers, Laboratory Scientists, Clinical Research Managers, Clinical Research Associates, Data Managers, Data Entry Administrators, Pharmacovigilance, Auditors, Regulatory Affairs Managers and IT experts to professionally accomplish the above stated tasks in a proficient team-oriented manner, exercising strong interpersonal skills.
- To manage vendors/contractors hired for statistical or data management activities
Education Minimum Requirement:
- Minimum of a Master of Science (or International equivalent) in Statistics or related
Required Experience and Skills:
- 5 or more years experience as Statistician in human or animal pharmaceutical industry.
- Ability to understand and implement regulatory regulations and company procedures.
- Ability to work independently and efficiently, in a project team environment
- Must be able to speak and write English
- Proactive, pragmatic, flexible, service minded and able to work under (time) pressure
Preferred Experience and Skills:
- Knowledge of USDA/CVB, FDA/CVM, EMA/CVMP and VICH Guidelines.
- Knowledge of Animal Health or Veterinary practices
- Knowledge of Quality Control, Assay Development, Testing Procedures
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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