About the Role
We are seeking a Manager, Biostatistics to provide statistical expertise in the design, analysis, and interpretation of clinical studies. This role supports project teams across multiple phases of drug development, ensuring that statistical methodologies are appropriately applied and that study results are accurately reported. The Biostatistician collaborates closely with cross-functional teams including clinical, data management, and programming, and may contribute to regulatory submissions and publications.
Requirements
Experience:
Minimum 8 years in biostatistics, with leadership experience in clinical trials.
Pharmaceutical, CRO, or related industry experience with clinical trials.
Technical Skills:
Proficiency in statistical programming (SAS, R), expertise in CDISC standards (SDTM, ADaM), and advanced statistical methodologies.
Oversight of multiple projects, technical strategy.
Strong oral and written communications skills, with the ability to effectively communicate internally and with clients.
Education: Ph.D. or Master’s in Biostatistics, Statistics, or a related field.
Knowledge: In-depth understanding of regulatory guidelines and submissions (e.g., ICH, FDA, EMA).
Soft Skills: Team leadership, conflict resolution, resource planning.
Qualification
Strong understanding of regulatory requirements for clinical trials, including ICH and FDA guidelines.
Experience in a leadership role, successfully managing teams and projects in a fast-paced environment.
Publication record in peer-reviewed journals, demonstrating expertise in biostatistics and clinical research.
Responsibilities
Lead and oversee the statistical analysis of clinical trials, ensuring adherence to regulatory guidelines and best practices.
Design statistical analysis plans (SAPs) and provide guidance on appropriate statistical methodologies for clinical studies.
Collaborate with clinical teams to define endpoints, statistical models, and analysis strategies that enhance study design.
Conduct exploratory data analysis and interpret complex datasets, translating statistical findings into actionable insights for stakeholders.
Mentor and develop junior statisticians, fostering a culture of statistical excellence and continuous learning within the team.