Manager/Senior Manager - Statistician - Contract Research Organization

Manager/Senior Manager - Statistician

A leading CRO is in search of Statisticians based at Bangalore.

Job Description :

- To work closely with technical lead of Client for statistical works.

- Provide direct supervision of other statisticians and programmers; train and mentor staff on processes.

- Author and/or provide input on both nonclinical and clinical reports, when applicable.

- Process capability analysis. Involves measurements of process capability indices like Cp, Cpk and Ppk.

- Calculation of tolerance intervals.

- Design of experiments.

- Acceptance sampling

- Analysis of stability studies

- Gage R&R analysis

- Calculation of alert limits for product surveillance.

Desired Profile :

- Expert knowledge of SAS software and general computing as it relates to research and development.

- Strong working knowledge of statistical data analysis and data management principles.

- Hands on experience creating SDTM, SEND and ADaM datasets

- Knowledge on CDISC and CDASH Standards

- Experience in handling manufacturing / non-clinical / Pre-clinical data

- Creating SAS MACROs, PROC MACONTROL, PROC SHEWHART

- Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical medical device business.

- Knowledge of pharmaceutical quality and regulatory requirements.

Education : UG -B.Sc - Statistics

PG : M.Sc - Statistics

Doctorate : Ph.D - Statistics

Location : Bangalore

Radhika Chatterjee