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.