- Provide Statistical inputs (design, sample size, washout period, sampling time points, pk parameters, Statistical analysis plan etc.) in Clinical study protocols according to the regulatory requirements.

- Literature search for the calculation of sample size related to the study molecule.

- Estimate sample size using SAS or R software based on pilot study data or literature data.

- Generation of Randomization schedule for all different designs using SAS software.

- Calculation of pk parameters and Statistical analysis such as Analysis of Variance (ANOVA), Confidence Intervals (C.I.) etc. using SAS and WinNonlin software.

- Statistical analysis of highly variable drugs and Narrow Therapeutic Index drugs, reference scaled approach as per US-FDA, European regulatory, Canada regulatory etc.

- Validation of Statistical outputs generated using SAS / WinNonlin.

- Interpretation of Statistical results.

- Provide Statistical inputs and summarize the required results in Clinical Study Report.

- Preparation of Biostatistics Report as per regulatory requirement.

- Generation of .xpt file (SAS transport file) as per US-FDA regulatory requirement.

- Preparation, review and implementation of Standard Operating Procedures (SOP- s) for Pk and Statistical analysis in Pk and Biostatistics department.

- Statistical analysis of In-Vitro Binding Bioequivalence study, IVRT and IVPT studies.

- Actively participation in regulatory audits like US-FDA, UK-MHRA, DCGI etc. for PK and Stats audits

- Preparation of technical Justifications/Reponses to PK and Statistics related queries raised by Sponsors and or Regulatory agencies.

- Knowledge on SAS code generation and validation

- Renewal and up-gradation of SAS and WinNonlin software.

- Perform validation (IQ, OQ and PQ) of SAS/WinNonlin software.

- Handling of data security along with computer systems.

- Coordination with the project management/Clinical/QA team for the submission of projects.

- Provide training and guidance to lower level and new staff in Pk and Biostatistics department

Education background:

- MSc Stats with SAS/ WinNonlin software knowledge Preferred

- Experience (Industry/therapy/function no. of years): 7 to 9 years

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.