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Job Description:

Role Objectives :

As one of the first Statistics for Study Design and Execution Leads to join the Bengaluru GCM team, this role will establish the statistical capability required to support evidence generation study design and execution, covering statistical analysis plan development, programming, and real-world data analysis.

You will also provide hands-on statistical design and programming support across the evidence generation portfolio, enabling Global Evidence Generation study teams to focus on scientific leadership, endpoint strategy, and final study decisions while GCM delivers analytical execution, statistical planning documentation, and RWD methodology support.

Key Responsibilities:





Initial Capability Build :

In the early build phase, work closely with Global Evidence Generation study leads and R&D; statistical counterparts to document the scope, standards, tools, templates, and handoff protocols that will govern statistical support activities performed by the GCM going forward
Develop programming standards, analysis templates, SAP shells, output shells, and QC checklists to support consistent and reproducible statistical execution as the team scales to two Leads
Identify gaps in tool access, data system connectivity, or methodology guidance that need to be resolved before statistical activities can be fully transitioned to the GCM and flag these to the AD in a timely manner
Support with development of SOPs and onboarding materials for all statistical programming and RWD analysis activities

Statistical Analysis Planning & Study Design Support:

Define appropriate statistical methods for RWD

📌 GCM Evidence Generation Study Design (Bengaluru)
🏢 Takeda
📍 Bengaluru