Neelesh Singh

About Neelesh Singh

My love for statistics runs deep within me and I am particularly drawn to the field of biostatistics. I desire to secure a position as a biostatistician in a CRO. Achieving perfection is a driving force for me and I approach tasks with unwavering determination and an unrelenting work ethic. My academic background includes completing an M.SC in Statistics.BIOSTATISTICAL KNOWLEDGE-1. Descriptive Statistics 2. Inferential Statistics( type l error and type ll error, hypothesis, level of significance, p-value, Confidence Interval)3. Parametric and Non-Parametric test4.Correlation and Regression (logistics regression)5. Conclusion and interpretation of statistical test6. Knowledge of Clinical trial and its phases Survival Analysis8. Basic knowledge of Bioequivalence and Bioavailability 9. Pharmacokinetic, pharmacodynamic and Bioequivalence analysis10.Basic understanding of sample size calculation11.Randomization generation for 2x2 crossover study and parallel study12.Basic knowledge of CDISC13.Basic knowledge of Protocol,eCRF, Statistical Analysis Plan,Mockshell.STATISTICAL SOFTWARE KNOWLEDGESAS SOFTWAREData management: Concatenating, merging,handling missing values,Creating data structures,Reading raw data files.Statistical SAS programming:PROC MEANS, PROC FREQ, PROC IMPORT, LIBNAME,INFILE,PROC PRINT,PROC TRANS POSEPROC UNIVARIATE, PROC TTESTClinical Trail Reports:PROC REPORT, Table listings and figures(TLF)Expertise in SAS/Base with basic knowledge of - PROC SQL,MACRO R-STUDIO KNOWLEDGEImport DataData ManipulationData Visualization Data Analysis

Experience

1. Biostatistician

   ICBio Clinical Research: CRO

   Apr 2024 — Present · Bengaluru, IN

   Biostatistician with focused expertise in BABE (Bioavailability/Bioequivalence) studies and clinical trials, specializing in statistical analysis, study design, and regulatory-compliant reporting and preparation of statistical reports for regulatory submissions. Proficient in SAS and R, with strong understanding of GCP and regulatory guidelines. Committed to delivering accurate, high-quality statistical outputs. Successfully performed statistical analysis for 80+ BABE (BA/BE) studies in compliance with regulatory guidelines. Led biostatistical responses and represented the function in ANVISA and NPRA regulatory reviews.

Education

• Lucknow University

  Master of Science (Statistics)

• St. Joseph High School Rajajipuram Lucknow

  High School , Science

• NAVYUG KANYA MAHAVIDYALAYA, RAJENDRA NAGAR

  Bachelor of Science (SPM), Mathematics and Statistics

• St. Joseph Inter College Rajajipuram Lucknow

  Intermediate , Science