Senior Director, Biostatistics

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Salary: $250,000 - $330,000 per year

Our Client was founded in 2013 by industry leaders in biotechnology, neuroscience, and antibody drug discovery.

401(k)

401(k) matching

Dental insurance

Health insurance

Life insurance

Paid time off

Retirement plan

Vision insurance

Job Details:

Are you passionate about using your statistical expertise to drive the development of innovative therapies for life-altering diseases? We are seeking an experienced and passionate Permanent Senior Director of Biostatistics to join our dynamic team in the life sciences industry. In this role, you will lead a team of biostatisticians and provide strategic statistical input to drug development projects in the areas of Neurology, Rare Diseases, and Neurodegenerative Disorders. You will also be responsible for the statistical aspects of regulatory submissions and liaisons with the FDA. This role is a unique opportunity to be at the forefront of scientific innovation and make a significant impact on patient lives.

Responsibilities:

• Provide leadership and strategic direction to a team of biostatisticians, fostering a collaborative and innovative environment.
• Serve as the statistical expert on drug development project teams, providing strategic input on study design, data analysis, and interpretation.
• Oversee the development and implementation of statistical analysis plans for clinical trials, ensuring the use of appropriate statistical methodologies.
• Lead the statistical aspects of regulatory submissions to the FDA, including the development of submission strategies and the preparation of statistical sections of submission documents.
• Collaborate with cross-functional teams to ensure the accurate and timely completion of statistical deliverables.
• Stay abreast of the latest developments in biostatistics and regulatory guidance, implementing new methodologies as appropriate.
• Ensure the quality and integrity of data analysis and reporting, adhering to company and regulatory standards.

Qualifications:

• A Ph.D. in Biostatistics, Statistics, or a related field.
• A minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with a focus on Neurology, Rare Diseases, and Neurodegenerative Disorders.
• Proven experience with regulatory submissions to the FDA, including NDA and BLA submissions.
• Strong knowledge of statistical programming languages (e.g., SAS, R).
• Demonstrated leadership and team management skills, with the ability to inspire and motivate a team.
• Excellent communication skills, with the ability to explain complex statistical concepts to non-statisticians.
• Strong problem-solving skills and the ability to think strategically and creatively.
• A commitment to staying abreast of the latest developments in the field of biostatistics and regulatory guidance.
• A passion for improving patient lives through the development of innovative therapies.

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