Director, Biostatistics

Job Description

CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

Job Summary:

Lead biostatistics and data management functions. This role is critical in ensuring robust study design, statistical analysis, data integrity, effective data management and regulatory interactions to support our product development and evidence generation activities.

Responsibilities

• Build and lead the biostatistics and data management teams, providing strategic direction and oversight.
• Supervise personnel supporting biostatistics activities for individual projects, including the design, statistical plan, analysis, and interpretation of clinical studies, ensuring appropriate statistical methodologies are applied.
• Develop and maintain data management standards, processes, and systems to ensure accurate, complete, and timely data collection, processing, and reporting.
• Ensure compliance with regulatory requirements and industry standards for biostatistics and data management.
• Work closely with cross-functional teams including clinical development, medical affairs, regulatory, and other departments to support product development and post-market activities.
• Drive innovation in biostatistical methods and data management practices, identifying opportunities for process improvements, efficiency and best practices.
• Communicate statistical and data management results to internal and external stakeholders, representing the company in interactions with regulatory agencies, key opinion leaders, and scientific communities.
• Provide coaching and training on statistical concepts to wider team.

Qualifications

Knowledge, Skills and Abilities:

• Strong expertise in clinical trial design, statistical analysis, and data management.
• Proven leadership experience with the ability to build, manage, and mentor a global team.
• In-depth knowledge of regulatory requirements and industry standards (e.g., FDA, ISO).
• Proficiency in statistical software (e.g., SAS, R, Minitab) and clinical data management systems (e.g., EDC systems).
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.
• Ability to manage multiple projects and meet deadlines.

Work Environment:

• Normal office environment.
• Sedentary to light physical effort necessary to perform the job.
• Extensive contact with employees and outside researchers.
• Some travel to company locations or meetings is required.

Experience:

• Minimum of 10 years of experience in biostatistics and data management within the medical device, pharmaceutical, or biotechnology industries. Experience in Ophthalmic devices is desired.

Education:

• Advanced degree (PhD or MSc) in Biostatistics, Statistics, Data Science, or a related field.

Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $192,319.00 and $ 295,875.00 per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

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