Job Description

We have a current opportunity for a Principal Biostatistician on a permanent basis. The position will be remote. For further information about this position please apply.

Job Title: Principal Biostatistician

Location: Remote

Job Type: Full-Time

About Us: We're partnered with a leading Contract Research Organization (CRO) dedicated to providing high-quality clinical research services to the pharamceutical industry.

Job Summary: We are seeking a highly skilled and experienced Principal Biostatistician to join our dynamic team. The Principal Biostatistician will play a critical role in the design, analysis, and interpretation of clinical trials, ensuring the integrity and accuracy of statistical data. This position requires a deep understanding of biostatistics, clinical trial methodology, and regulatory requirements.

Key Responsibilities:

• Lead the statistical design and analysis of clinical trials, including the development of statistical analysis plans (SAPs).
• Provide expert statistical consultation to project teams, clients, and regulatory agencies.
• Ensure the accuracy and integrity of statistical data and results.
• Collaborate with cross-functional teams, including clinical operations, data management, and medical writing.
• Develop and validate statistical models and methodologies.
• Prepare and review statistical sections of clinical study reports, regulatory submissions, and publications.
• Stay current with industry trends, regulatory guidelines, and best practices in biostatistics.
• Mentor and train junior biostatisticians and other team members.

Qualifications:

• Ph.D. or Master's degree in Biostatistics or Statistics
• Minimum of 5 years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry.
• Strong knowledge of clinical trial design, statistical methodologies, and regulatory requirements (e.g., ICH, FDA, EMA).
• Proficiency in statistical software (e.g., SAS, R).
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Strong problem-solving and analytical skills.
• Experience with regulatory submissions and interactions with regulatory agencies is a plus.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Collaborative and supportive work environment.

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