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Position Overview: We are looking for a seasoned professional to join our team as the Director of Biostatistics. The Director of Biostatistics will play a critical role in shaping the direction of our clinical development programs. This individual will lead a team of statisticians and collaborate closely with cross-functional teams to design, analyze, and interpret clinical trials data, ensuring the highest standards of statistical rigor and accuracy.
Key Responsibilities
Leadership: Provide strategic direction and leadership to the biostatistics team, fostering a culture of excellence, collaboration, and innovation.
Statistical Design: Lead the statistical design of clinical trials, including sample size determination, randomization schemes, and statistical analysis plans.
Data Analysis: Oversee the analysis of clinical trial data, ensuring adherence to protocol and regulatory guidelines, and providing statistical insights to support decision-making.
Interpretation and Reporting: Interpret study results and communicate findings effectively to internal stakeholders, regulatory agencies, and external partners through statistical reports and presentations.
Regulatory Compliance: Ensure compliance with regulatory requirements and industry standards for statistical analysis and reporting, including FDA and EMA guidelines.
Cross-functional Collaboration: Collaborate closely with clinical development, regulatory affairs, medical affairs, and other functional areas to integrate statistical considerations into overall development strategies.
Methodological Innovation: Stay abreast of advancements in statistical methodologies and apply innovative approaches to address complex scientific challenges.
Mentorship and Development: Provide mentorship, coaching, and professional development opportunities to the biostatistics team members, fostering their growth and career advancement.
Qualifications
Ph.D. in biostatistics, statistics, or a related field.
8+ years of experience in biostatistics within the pharmaceutical or biotechnology industry.
Proven track record of leading statistical efforts for clinical development programs from Phase I through Phase III.
Strong knowledge of statistical methodologies, study design, and regulatory requirements for clinical trials.
Proficiency in statistical software such as SAS, R, or Python.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Prior experience managing and developing a team of statisticians is highly desirable.
Demonstrated ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.
Seniority level
Director
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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