Sr Biostatistician Ii Bengaluru

Sr Biostatistician Ii Bengaluru

15 Aug
|
Thermo Fisher Scientific
|
Bengaluru

15 Aug

Thermo Fisher Scientific

Bengaluru

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 easy to complex study design matters, directly contributing to straightforward 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 proc

📌 Sr Biostatistician Ii Bengaluru
🏢 Thermo Fisher Scientific
📍 Bengaluru

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