Sr Biostatistician II

Thermo Fisher Scientific — Bangalore, India

Work Schedule Second Shift (Afternoons) Environmental Conditions Office Job Description Summarized Purpose: Serves as a project lead or lead statistician to deliver on tasks/responsibilities for multiple complex protocols, projects, or NDA projects, including coordinating with other divisions and interacting with the client and regulatory agencies. Mentors others in the application of more complex statistical methodologies. Performs project management functions relating to the administrative and scientific activities of team members across multiple complex projects. Provides senior-level oversight of statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Represents the department to clients on simple to complex study design matters, directly contributing to simple to complex study proposals and bids and representing the department at bid defenses. Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies. Essential Functions: • Ensures compliance with the activities outlined in the department's SOPs and contribute changes as needed. Follows departmental procedures for statistical analyses and programming work. • Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across challenging projects; provides senior review on projects. Leads team members across multiple complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed. • Reviews sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Reviews randomization related documentation. • Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and proced

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