Assistant Manager- Biostatistics

Core Purpose of the Role:

• To perform Biostatistical activities in Biometrics Department for Clinical Studies Phase 1-4

Role Accountabilities

• Reviewing protocol
• SAP & RAP preparation and implementation

• Sample size calculation
• Provides statistical consultations
• Preparing and reviewing randomization list
• Perform Statistical analysis as per SAP and Protocol
• Reviewing of SDTM and AdAM dataset
• Preparing and reviewing of tables, listing and graphs, as applicable
• Preparing and reviewing of statistical report, as applicable
• Provides support for blinding and unblinding documentations

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  Preparing and reviewing standard operating procedures
• Training/Guiding/Mentoring associate biostatisticians and junior programmers.
• Objectives setting and appraisal for the team
• Facing client to answer statistical queries

Demonstrated Capability

• Expert in SAS programming language
• Clinical Trials Exposure Pharmacokinetics studies and Phase I-IV studies preferably rich experience in Phase I-IV).