Job Details

Responsible for Statistical Review of CSR outputs on Phase 1/BA/BE studies on multiple projects.
Serve as the Lead Statistician for several projects. As a lead, Responsible for below activities :
POC for programmers for queries/clarifications/issues related to layout, study design, statistical analysis.
POC for client for discussion on queries/issues along with the lead programmer
Work closely with the lead programmer for ensuring the quality and completeness of the deliverables as per the client expectations
Suggest/Provide inputs or take up initiatives for process improvements, specifications, quality improvement etc.
Work closely with lead programmer and other statisticians for establishing smooth functioning of work related to PK/PD analysis
Provide inputs to statistical analysis for PK and answer any queries raised by the programming team.
Also work closely with the client on streamlining the process for generating outputs for PK/PD.
The current pipeline is only for Phase 1 and but Phase 2-3 work may be given in future, the role will be the same then as well, but complexity of the analysis will be higher and Statistician will play a key role.
Support other projects for randomization/unbinding activities or protocol QC, inputs to SAP etc whenever there is a requirement. (This could be any phases)

Master's Degree in Statistics (or related discipline); Ph.D. preferred
Six years relevant experience with drug development statistical analysis
Must have good hands-on exp in CSR Review, Randomization, Mock Shell creation, review statistical reports
Proficiency in SAS programming
Excellent communication skills
Exp in SAP Writing is good to have but not mandatory

Reference ID - Gh/PHL/Principal or Senior Statistician/ JC//16032018//74490