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Vishali Vijayanagaram

@vishalivijayanagaram

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Principal Biostatistician specializing in clinical trial design, analysis, and regulatory support.

India

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What I'm looking for

I seek a role leading statistical design and analysis within collaborative clinical teams, contributing to regulatory submissions, publications, and methodological innovation.

I am a Principal Biostatistician with experience leading statistical design, sample size determination, and regulatory responses for clinical trials across phases and therapeutic areas, including immunology and bioavailability studies.

I have served as project statistician and statistics lead, supporting protocol/SAP/CSR review, ClinicalTrials.gov registration, AE/SAE review, TLF and ADaM specifications, and manuscript collaboration. I implemented Spotfire for TLSR, prepared review template codes, and researched sample size approaches for RBA designs.

My background includes hands-on analysis using SAS and R, PK analysis exposure to Phoenix WinNonlin, and experience with a range of statistical methods (ANOVA, MMRM, Cox models, logistic regression, meta-analysis). I hold an M.Sc. in Biostatistics and have published in peer-reviewed literature.

Experience

Work history, roles, and key accomplishments

Current

Principal Statistician

Current

Eli Lilly Services India Private Limited

Aug 2023 - Present (2 years 7 months)

Served as project statistician and Statistics Lead for immunology studies, developing protocols, SAPs and sample size determinations, supporting regulatory responses and ClinicalTrials.gov disclosures to ensure compliance and data accuracy.

Protocol Development SAP Regulatory Submissions SAS R Safety Data Review

Executive (Biostatistician)

Syngene International Limited

Jul 2021 - Aug 2023 (2 years 1 month)

Reviewed statistical documents and supported randomization planning and sample size estimation for BA/BE studies, performed PK analyses and validated tables using SAS to support study reporting.

BA BE Study Design Randomization SAS R

Junior Analyst

Indegene Pvt. Ltd.

Jul 2020 - Jul 2021 (1 year)

Prepared and analyzed clinical and hospital datasets, applied statistical methods including regression and meta-analysis, and assisted in development of statistical plans and HEOR presentations.

Clinical Data Analysis regression ANOVA Meta Analysis SAS R HEOR Statistical Planning

Intern

Healthminds Pvt. Ltd.

Jan 2020 - Feb 2020 (1 month)

Analyzed clinical and survey data using descriptive statistics, chi-square/Fisher's exact tests and mixed-effect models, and reviewed data management and statistical analysis protocols.

Descriptive Statistics Chi Squared Fisher'S Exact Test R SPSS