About the Role
We are seeking a Senior Biostatistician 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:
4-7 years of experience.
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.
Advanced programming;Â experience in clinical trial datasets.
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: Familiar with regulatory submissions, study design.
Soft Skills: Leadership, mentoring, cross-functional communication.
Qualification
Demonstrated experience in designing and analyzing clinical trials, with a solid understanding of regulatory requirements.
Experience with adaptive trial designs and real-world evidence studies.
Prior experience in project management and leading statistical projects.
Responsibilities
Design and implement statistical analysis plans for clinical trials, ensuring compliance with regulatory standards.
Conduct thorough statistical analyses using appropriate methodologies, including survival analysis, longitudinal data analysis, and Bayesian approaches.
Collaborate with clinical teams to interpret results and provide actionable insights that inform study design and decision-making.
Mentor junior statisticians and provide guidance on best practices in statistical modeling and programming.
Stay current with emerging statistical methodologies and software tools, integrating them into the team's workflow to enhance productivity.