Senior Specialist, Biostatistics - #19543867
Merck & Co., Inc.
Our Animal Health Research Laboratories team work tirelessly to invent solutions to improve the health and wellbeing of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges.
The primary functions of this position vary according to specific role and clients supported. Each accountablility may not apply to all statisticians:
- To apply solid knowledge of statistical methodology and experimental design to plan laboratory and field animal studies for pharmaceutical and biologic 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 Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM), European Medicines Agency (EMA) Committee for Medicinal Products for Veterinary use (CVMP), United States Department of Agriculture (USDA), 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, , Pharmacovigience, 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
The successful statistician will follow Good Clinical/Laboratory/Manufacturing Practices (GxP), display unquestionable ethics, maintain patient and owner privacy, and protect confidentiality of company intellectual property, and will have skills in a majority of:
- Conventional, Adaptive and/or Bayesian Experimental Design
- Statistical Analysis
- Statistical programming skill in SAS or other statistical package
- Data Management processes
- Electronic Data Capture
- Knowledge of FDA/CVM, EMA/CVMP, USDA/CVB and VICH Guidelines. A working knowledge of EPA, FDA/CDER/CBER/CDRH, EMA/CHMP, and ICH Guidelines is helpful
- Knowledge of Clinical Research and Clinical Trials
- Knowledge of Animal Health or Veterinary practices
- Knowledge of Clinical Monitoring and Auditing
- Knowledge of Quality Control, Assay Development, Testing Procedures
- Knowledge of Process Validation, Process Improvement, Six Sigma
- Experience with Regulatory submissions
- Self-initiator with strong planning skills
- Strong interpersonal skills, negotiation skills, and teamwork focus
- Strong verbal and written communication skills
- Strong presentation skills
- Minimum of a Masters of Science (or International equivalent) in Statistics or related.
- 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
Please note that travel may be required up to 10% of the time. Travel requirements will vary greatly depending on study activities and may require weekend travel.
Our Animal Health division is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society and our planet. We offer one of our industry's most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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