Merck Senior Specialist, Biostatistics in Des Moines, Iowa
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 accountability 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 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 preserving and improving health, well-being, and performance of animals and the people who care for them. 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.
Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.
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.
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 .
Invent. Impact. Inspire.
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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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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
Flex Time, Remote Work, Telecommuting
Valid Driving License:
Number of Openings:
Requisition ID: R120866
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