Kumar Naidu

About Kumar Naidu

To formulate, implement, and enforce proper data collection policies and procedures•To establish data quality standards to ensure set standards are met•To perform and document procedures for data preparation including data cleaning, standardization and analysis•To participate in the review of Clinical trial documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).•Finalization of data management plan (DMP) and maintaining DMP throughout life-cycle of study project to ensure DMP is followed according to study design and requirement•Finalize statistical methods for clinical study,bioequivalence and pre-clinical study protocols.•Review study objectives defined in the protocol or search from articles.•Literature search and finalization of sample size for clinical and bioequivalence studies using appropriate software•Finalization of tables, listing and graphs using appropriate software as outlined by the DMP•Perform quality control of tables, listings, graphs and derive data set for efficacy analysis as suggested by the QA personnel.•Preparation of e- CRF database in SAS PheedIt 3.03.•Reviewing clinical trial data after data entry in the pre-specified database.•Analysis and review of interim and final statistical analysis reports.•Provide support for publication of clinical trial results and resolution of reviewer queries related to statistics.•Provide support for SEC Meetings and resolution of regulatory queries of clinical studies.•Provide support for resolution of regulatory queries of bioequivalence studies.•Ensure data management staff are trained and adhere to project-specific, global, standardized data management processes.•Provide assistance in in-vitro dissolution data interpretation with respect to the available PK data and literature.•Provide assistance in decision making for test batch selection for pivotal bioequivalence study from pilot study data.

Experience

1. Deputy General Manager

   Ipca Laboratories Limited

   Jan 2026 — Present

Education

• Institute of science

  Masters in statistics, Statistics

  2005 — 2007

Skills

• Clinical Research
• Pharmaceutical Industry
• Data Analysis
• Statistics
• Sas Programming
• Statistical Modeling
• Logistic Regression
• Spss
• CRO
• Biostatistics
• Data Management
• Clinical Trials
• Statistical Programming
• Epidemiology
• Good Clinical Practice (Gcp)
• Sas
• CRO Management
• Clinical Data Management
• Validation