Associate Director, Biostatistics
About The Position
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.
Requirements
- 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
- 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
Nice To Haves
- 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
Responsibilities
- 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.
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Manager
