Associate Director, Biostatistics

Job Description

Join Our Companys Rahway Animal Health Team

Our Companys 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:

• Masters 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 worlds 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:

Preferred Skills:

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The salary range for this role is

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 employees 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 can apply for this role through (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

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