Senior Biostatisticians

• Contribute to study design, protocol development, sample size calculation, CRFs, Results Interpretation, clinical study report, and addressing questions from regulatory agencies.
• Collaborate with vendor to develop and maintain SAPs, including the derived variables, the templates of statistical TFLs.
• Provide guidance to the study team for all statistical activities while collaborating with a data manager to ensure high-quality data.
• Work collaboratively with cross functional teams to ensure timelines are being met.
• Manager CROs by establishing procedures through regular interaction, setting expectations on deliverables and timelines to guide vendor biostatisticians and statistical programmers.
• Provide input for regulatory interaction or by writing the interaction document; may participate in meeting or teleconferences with Health Authorities.
• Coordinate with all team members to prepare the statistical analyses for IB, DSUR update, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities, attend team meetings.

Requirements:

• PhD in Biostatistics/Statistics or related field and at least 4+ years of biostatistics. experience in pharma OR MS in Biostatistics/Statistics or related field and at least 7+ years of pharma experience.
• Must possess strong statistical programming technical expertise in SAS.
• Experience in Phase III and late phase clinical trials.
• Experience providing CRO/vendor oversight, ensuring deliverables and timelines are being met.
• Knowledge of statistical methodologies, current drug development trends, and regulatory environments.
• Ability to communicate effectively and interact with cross functional teams.