Shefali
Biostatistician | Clinical Research Strategist | Expertise in SAS, R
- Role
- Lead Biostatistician at Fortrea
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shefali
With extensive experience in biostatistics, I have contributed to the success of clinical trials across all phases (Phase 1 to Phase 4), specializing in BA/BE trials as well and working across diverse therapeutic areas, including respiratory, oncology, neurology, gastrointestinal, and more.My expertise spans the full spectrum of biostatistical activities, including: • Randomization and sample size calculations • Development and validation of SDTM datasets and ADaM datasets • Preparation of Statistical Analysis Plans (SAPs) • Creation and QC of TFLs (Tables, Figures, and Listings) • Regulatory submissions and compliance •. Drafting aCRF and QCing the annotated documents too.I focus on crafting detailed and precise TFLs to support data analysis and decision-making. My hands-on approach ensures the delivery of high-quality, compliant, and impactful statistical outputs that meet both clinical and regulatory expectations.
Experience
Lead Biostatistician
Jul 2023 — Present · Bengaluru, IN
Education
Amity University Noida
BSc Actuarial Science, Statistics
2012 — 2015
Amity University Noida
M stats, Statistics
2015 — 2017
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