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 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
📌 Sr Biostatistician II (Bengaluru)
🏢 Thermo Fisher Scientific
📍 Bengaluru
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.