Director of Biostatistics
Boston / $210000 - $250000 annum
INFO
$210000 - $250000
LOCATION
Boston
Permanent
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.
CONTACT
Tim Lucas
Manager
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Please register your interest by sending your CV to Rosie Walsh through the ‘Apply’ link
To Apply for this Job Click Here
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