Director, Global Data Management & Statistics
- Florham Park, NJ
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 are:
- Define statistics and data management department policies and procedures to be compliant with regulatory guidelines, industry practices, and corporate and divisional governance
- Develop internal and contract staff to apply appropriate statistical methodology and experimental design to laboratory-challenge and clinical field trials for pharmaceutical and biological veterinary compounds for Clinical Research, Research and Development, Discovery, Pre-Clinical and Drug Metabolism
- Develop internal and contract staff to create and maintain clinical data collection tools and databases following good data management practices
- Provide statistical direction and support for submission of study results to appropriate global regulatory agencies, and serve as statistical representative on scientific issues
- Develop new methodology and tools to improve compliance and global standardization leading to gains in efficiency
I - Key Attributes
- Conventional, Adaptive and/or Bayesian Experimental Design
- Statistical Analysis of pharmaceutical development studies
- Data Management processes and tools including Electronic Data Capture
- Knowledge of FDA/CVM, EMA/CVMP and VICH Guidelines, especially with respect to GCP and GLP. A working knowledge of FDA/CDER, FDA/CBER, FDA/CDRH, EMA/CHMP, ICH Guidelines is helpful.
- Knowledge of Clinical Research and Clinical Trials
- Knowledge of Veterinary practices
- Knowledge of Clinical Monitoring and Auditing
- Knowledge of Quality Control, Assay Development, Testing Procedures
- Knowledge of Good Manufacturing Practices (GMP)
- Knowledge of Process Validation, Process Improvement, Six Sigma
- Experience with Regulatory submissions
- Strong interpersonal skills, negotiation skills, and teamwork focus
- Demonstrated skill in independently developing or applying new statistical methodology, or pursuing solutions to various technical problems
- Experience in publishing and presenting trial results or statistical methods to scientific community
- Statistical programming skill in SAS or other statistical package
- Strong verbal and written communication skills
II - Required Experience
- Minimum of a Masters of Science (or International equivalent) in Statistics or related field. PhD or other doctorate preferred.
- 10 or more years experience as Statistician in human or animal pharmaceutical industry with proven track record of leading successful regulatory submissions.
- 5 or more years direct involvement with data management activities
- 5 or more years in managing technical or scientific staff, preferably statistical or data management in pharmaceutical development
- Ability to understand and implement regulatory regulations and company procedures.
- Must be able to travel up to 10% of the time. Travel requirements will vary greatly depending on study activities and may require weekend travel.
- Ability to work independently and efficiently, in a project team environment
- Must be fluent in oral and written English. Working knowledge of French, Dutch or German preferred.
- Proactive, pragmatic, flexible, service minded and able to work under (time) pressure
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.
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.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at firstname.lastname@example.org
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully
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:
Valid Driving License:
Number of Openings:
Back to top