Akansha Gupta
Biostatistician
Ahmedabad
Summary
Biostatistician with hands-on experience in clinical trials and medical device research, specializing in advanced statistical analysis and regulatory-compliant reporting. Actively involved in clinical study design support, SAP development, SDTM dataset creation, and CSR statistical sections across Cardiovascular and Orthopedic therapeutic areas. Proficient in R and SAS, with a strong working knowledge of FDA regulations, ICH-GCP guidelines, and CDISC standards. Driven to grow as a biostatistician by taking on increasing analytical ownership and delivering high-impact, decision-ready insights.
Overview
1
1
year of professional experience
5
5
Certificates
2
2
Languages
Work History
Biostatistician
Meril Life Sciences Pvt. Ltd.
05.2025 - Current
- Therapeutic Area: Cardiovascular and Orthopedic therapeutic areas.
- Working as a Biostatistician on multiple clinical trials and PMCF studies for medical devices across Cardiovascular and Orthopedic therapeutic areas.
- Involved in protocol review and study design support, including evaluation of study objectives, endpoints, estimands, analysis populations, and statistical methodologies.
- Performed sample size calculations based on reference literature and prior studies, considering effect size, variability, power, significance level, and dropout assumptions.
- Performed advanced statistical analyses, including: Descriptive and inferential statistics for continuous and categorical endpoints, including Hypothesis testing for parametric and non parametric tests. Longitudinal and change-from-baseline analyses across study visits Subgroup and exploratory analyses for secondary and safety objectives Survival analysis (Kaplan–Meier estimation, log-rank tests, censoring handling) Regression modeling (Linear, Logistic, Multivariable) Statistical Validation & Quality Control: Validation of analysis datasets and outputs, ensuring consistency with SAP specifications and study protocols.
- Generated Tables, Listings, and Figures (TLFs) using SAS and R, aligned with protocols, SAPs, and regulatory requirements.
- Conducted data interpretation and statistical inference, translating results into clinically meaningful insights for internal stakeholders.
- Created SDTM datasets from raw clinical data in compliance with CDISC SDTMIG; familiar with SDTM domains, controlled terminology, and metadata standards.
- Supported interim analysis activities and developed understanding of Bayesian and adaptive trial concepts.
- Contributed to authoring Statistical Analysis Plans (SAPs) and preparing statistical sections of Clinical Study Reports (CSRs).
- Ensured compliance with FDA regulations, ICH-GCP guidelines, and internal SOPs, collaborating closely with clinical, data management, regulatory, and medical writing teams.
- Key Studies: PEEK OPTIMA| BioMime Branch 1 | Landmark Trial | Freedom 400 | Daffodil PMCF | Myval Inception
Intern Biostatistician
Pharma-Stats
12.2024 - 04.2025
- Therapeutic Area: Clinical Trial – Hair Oil Safety & Efficacy (Phase 2)
- Worked on a Phase 2 clinical trial evaluating the safety and efficacy of a hair oil product.
- Hands-on experience with real-time clinical data, including data handling, cleaning, and preparation.
- Applied statistical techniques such as One-Sample t-Test and Paired t-Test to assess the effectiveness of the product.
- Performed descriptive statistics, frequency analysis, and graphical representation to summarize categorical variables.
- Interpreted p-values, confidence intervals, and hypothesis testing to draw meaningful conclusions from trial data.
- Generated visualizations, including histograms, bar charts, and boxplots, to enhance data interpretation.
- Gained a strong understanding of clinical trial design, regulatory requirements, and biostatistical methodologies in pharmaceutical research.
Education
M.Sc. - Statistics
University of Lucknow
01.2021
B.Sc. - Statistics
University of Lucknow
01.2019
Intermediate - Science Stream
Rani Laxmi Bai School
Lucknow01.2016
High School - undefined
St. Don Bosco School
Lakhimpur Kheri01.2014
Skills
Statistical Tools & Programming: SAS: Data manipulation, data transformation, PROC SQL, Macros, generating Tables, Listings, and Figures (TLFs) R: Data wrangling, statistical analysis, r2rtf for RTF reports, hypothesis testing, and visualization using ggplot2 SPSS: Basic statistical tests and regression modeling Excel: Advanced data analysis, Pivot Tables, and data summaries
Bio-Statistical Skills: Hypothesis Testing: t-Test, Paired t-Test, ANOVA, ANCOVA, Chi-Square Test, Kruskal-Wallis Test, Wilcoxon Rank Sum Test Clinical Trials Knowledge: Phases of clinical trials, Study Objectives, Standard Operating Procedures (SOPs), Statistical Analysis Plan (SAP), and Mockshell creation Regression Analysis: Linear, Logistic, and Multivariate analysis
Statistical software
Data management
Study design
R programming
Statistical modeling
Bayesian methods
SAS programming
Clinical trials
Longitudinal data
Time series analysis
Teamwork
Problem-solving
Excellent communication
Critical thinking
Data visualization
Analytical skills
Data analysis
Statistical analysis
Hypothesis testing
Statistical reporting
Certification
ICH-GCP Certified
Timeline
Biostatistician
Meril Life Sciences Pvt. Ltd.
05.2025 - Current
Intern Biostatistician
Pharma-Stats
12.2024 - 04.2025
B.Sc. - Statistics
University of Lucknow
Intermediate - Science Stream
Rani Laxmi Bai School
High School - undefined
St. Don Bosco School
M.Sc. - Statistics
University of Lucknow
Languages
English
Hindi
STRENGTHS
- Quick Learner & Problem Solver.
- Strong interpersonal and communication skills.
- Strong Analytical & Statistical Aptitude.
- Effective Time Management & Leadership.
- Honest, Responsible & Dedicated Professional.
DECLARATION
I hereby declare that the information provided above is true and correct to the best of my knowledge and belief. Date: 26th January 2026 Akansha Gupta
STRENGTHS
- Quick Learner & Problem Solver.
- Strong interpersonal and communication skills.
- Strong Analytical & Statistical Aptitude.
- Effective Time Management & Leadership.
- Honest, Responsible & Dedicated Professional.