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Nisha Gupta
Biostatistician II
Biostatistician II
Nisha Gupta is a Biostatistician with 7+ years of experience in clinical research and statistical programming across Phase I–III clinical trials, bioequivalence, pharmacokinetics, and in-vitro studies. Skilled in SAP development, randomization, and statistical modeling using SAS and Phoenix WinNonlin, she delivers regulatory-compliant statistical outputs and datasets aligned with CDISC standards (SDTM/ADaM). Nisha collaborates closely with cross-functional teams, leads statistical programming activities, and ensures the accuracy and reliability of analysis results for global clinical studies.
FORMERLY AT
IQVIA RDS (India) Pvt. Ltd.
LOCATION
Bengaluru, India
AVAILABILITY
Full Time
Skills
CDISC (SDTM/ADaM)
CDISC Standards
Microsoft Office
MS Office
Phoenix WinNonlin
SAS
Work Experience
Biostatistician II
IQVIA RDS (India) Pvt. Ltd.
March 2022 – Present
- Develop Statistical Analysis Plans (SAPs), TLF specifications, and dataset requirements.
- Lead statistical programming activities and guide programming teams.
- Collaborate with clients to align statistical analysis strategies and study deliverables.
- Conduct model fitting and perform statistical review of reports and outputs.
TECHNOLOGIES
SAS, CDISC (SDTM/ADaM), Microsoft Office
Senior Executive – Biostatistics
Aleor Dermaceuticals (Alembic Group)
August 2020 – February 2022
- Conducted statistical analysis for topical product studies including IVRT, IVPT, and vasoconstrictor assessments.
- Managed SAP creation, protocol development, mock shells, and randomization for BA/BE studies.
- Reviewed and validated pharmacokinetic analyses and clinical statistical reports.
TECHNOLOGIES
SAS, Phoenix WinNonlin, CDISC Standards
Executive – Biostatistics
Clians Labs Pvt. Ltd.
December 2018 – August 2020
- Performed in vitro/in vivo bioequivalence and clinical endpoint analyses.
- Applied mixed models, regression, and survival analysis in SAS. .
- Supported study design and provided statistical input to cross-functional study teams.
TECHNOLOGIES
SAS, Phoenix WinNonlin, MS Office
