Associate Director, Biostatistics

Job description

Job Description Join Our Company’s Rahway Animal Health Team Our Company's Global Animal Health Research & Development (R&D) division is a pioneer in the discovery, development and registration of medicines, products, and therapeutics for animals. To strengthen the team responsible for our global initiatives, we are looking for a highly skilled and motivated individual to join our R&D team. Purpose of the Role The Associate Director Biostatistics will lead and oversee the planning and design of laboratory and field animal studies, and responsible for applying the knowledge of statistical methodology and experimental design to plan and design studies for the development of pharmaceutical and biologic veterinary compounds. Primary Functions: Conducting advanced statistical analysis and preparing comprehensive reports, and actively collaborate on research and development and clinical study reports, while also providing statistical review of externally generated reports. Acting as a statistical expert in regulatory submissions and compliance - responsible for supporting the submission of study results to regulatory agencies such as the FDA, EMA, USDA, and EPA; interacting with regulatory authorities on statistical issues related to product development, registration, investigations. Collaborating with cross-functional teams and providing statistical expertise - collaborating closely with veterinarians, project managers, laboratory scientists, clinical research managers, data managers, and other stakeholders. They provide statistical expertise and guidance to production, quality control, analytical testing, process control, process optimization, commercial operations, and marketing/sales teams. Mentoring and coaching junior statisticians - taking on a leadership role within the statistical team, providing guidance, mentoring, and training to junior statisticians. Key Attributes: Strong expertise in statistical methodology, advanced experimental design, and analysis techniques Proficiency in statistical programming languages such as SAS or R and familiarity with advanced statistical software packages Extensive experience in data management processes and electronic data capture In-depth understanding of regulatory guidelines and requirements from agencies such as FDA/CVM, EMA/CVMP, USDA/CVB, and VICH Comprehensive knowledge of clinical research, clinical trials, and animal health/veterinary practices Proficient in clinical monitoring, auditing, quality control, assay development, testing procedures, and process validation/improvement Experience with regulatory submissions and adherence to Good Clinical/Laboratory/Manufacturing Practices (GxP) Exceptional interpersonal, communication, and leadership skills Ability to work independently, lead project teams, and provide guidance to junior statisticians Proactive, pragmatic, adaptable, and able to thrive in a fast-paced and dynamic environment Required Experience: Master's degree or Ph.D. degree in Statistics Minimum 7 years experience as a statistician in the pharmaceutical or biologic veterinary industry, particularly in animal health clinical trials Proven track record of successfully leading and executing statistical projects in a regulated environment Strong understanding and implementation of regulatory regulations Animal Health 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. 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. Required Skills: Assay, Assay Development, Clinical Research, Clinical Trials, Cross-Functional Collaboration, Cross-Team Collaboration, Data Management, Data Science, Early Clinical Development, Numerical Analysis, Scientific Modeling, Statistical Programming, Teamwork, Waterfall Model Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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 propert