Manish Hire
Biostatistician
Mumbai
Summary
Accomplished Biostatistician with expertise in SAS and statistical analysis.Ability to express statistical concepts clearly to perople.Proven ability to determine sample sizes and develop robust statistical analysis plans for BA/BE studies. Strong analytical skills complemented by effective communication, ensuring precise interpretation of results and adherence to regulatory guidelines.
Overview
2
2
years of professional experience
3
3
Languages
Work History
Biostatistician
Macleods Pharmaceuticals Ltd., RnD
12.2023 - Current
- Give statistical input in the protocol for the BA/BE studies.
- Determination and justification of sample size.
- To developed randomization schedule for the different study designs.
- To perform statistical analysis for BA/BE studies.
- To developed Sas program's for various study designs.
- Developed SOP's as per regulatory guidelines.
- Give statistical interpretation of results.
Biostatistician
Healthcare Global Enterprises
04.2023 - 11.2023
- Determie sample size for cancer research studies.
- Developed SAP for various research studies.
- Perfrom graphical and statistical analysis for research studies of fellow doctors.
- Giving interpretation of statistical results and report writing.
Education
Master of Science - Statistics
K.B.C. North Maharashtra University
Jalgaon, Maharashtra 04.2001 -
Bachelor of Science - Statistics
Pratap College
Amalner, Maharashtra 04.2001 -
HSC - Science
Pratap College
Amalner, Maharashtra 04.2001 -
SSC -
G.S. Highschool
Amalner, Maharashtra 04.2001 -
Skills
Statitstical Tools : SAS (BASE,STAT,MACRO), SPSS,R -studio,Minitab,MS-Office
Sample size calculation
Statistical Analysis plan
Randomization technique
Knowledge of Descriptive and inferential Statistics, parametric and Non-parametric tests, Linear and logistic regression analysis
Data analysis,Data visualization and result interpretation
Detail knowledge about Bioavailability & Bioequivalence studies: croosover study design, definitions and calculation of Pharmacokinetic parameters, washout period,Intra-subject CV, Bioequivalence limits
Basic knowledge of the importance of SOP & Guidelines for submission studies
Statistical analysis using SAS: PROC MEANS,PROC FREQ,PROC UNIVARIATE,PROC GLM AND PROC MIXED
Extracurricular Activities
- Winner of Avishkar 2019 competition (phase-I) and Selected for (Phase-II) at University level.
- Winner of 19th National Children Science Congress 2011 competition at District level.
- Typing Certification 40 WPM.
Declaration
I hereby declare that the above said information is true to the best of knowledge and belief.
Place : Mumbai (Manish Hire)
Date :
Timeline
Biostatistician
Macleods Pharmaceuticals Ltd., RnD
12.2023 - Current
Biostatistician
Healthcare Global Enterprises
04.2023 - 11.2023
Master of Science - Statistics
K.B.C. North Maharashtra University
04.2001 -
Bachelor of Science - Statistics
Pratap College
04.2001 -
HSC - Science
Pratap College
04.2001 -
SSC -
G.S. Highschool
04.2001 -