Priya Sharma
42 Maple Ridge Road, Bangalore, Karnataka 560034, India
+91-80-4521-7834 | priya.sharma.biostat@gmail.com
https://www.linkedin.com/in/priyasharma-biostatistician

PROFESSIONAL SUMMARY

Accomplished Senior Biostatistician with over 10 years of experience in clinical trial design, statistical analysis, and regulatory submissions within the pharmaceutical and biotechnology industries. Expertise in oncology clinical trials across all phases, with proven track record in biomarker development, genomics data analysis, and statistical programming. Demonstrated ability to collaborate with cross-functional teams to drive data-driven decision making and support drug development programs from early phase through regulatory approval.

PROFESSIONAL EXPERIENCE

Senior Biostatistician
Novartis Oncology Solutions, Pune, Maharashtra
January 2020 - Present

Lead statistical design, analysis, and reporting for multiple Phase II and Phase III oncology clinical trials investigating novel targeted therapies and immunotherapies. Provide statistical expertise in protocol development, sample size determination, randomization strategies, and interim analysis planning. Collaborate closely with clinical, regulatory, and data management teams to ensure study objectives are met and data quality is maintained. Develop and review statistical analysis plans, table/listing/figure shells, and clinical study reports. Mentor junior biostatisticians and statistical programmers on best practices and regulatory requirements. Successfully supported two NDA submissions resulting in FDA approval.

Biostatistician II
Cipla Clinical Research, Mumbai, Maharashtra
June 2016 - December 2019

Conducted statistical analyses for Phase I and Phase II oncology trials, including dose-escalation studies and biomarker-driven basket trials. Designed and implemented adaptive trial designs to optimize patient enrollment and treatment allocation. Performed exploratory analyses of genomic data including NGS, RNAseq, and DNA biomarkers to identify predictive and prognostic factors. Developed SAS and R programs for efficacy and safety analyses, generating tables, listings, and figures for regulatory submissions. Collaborated with bioinformatics teams to integrate molecular data with clinical outcomes. Presented statistical findings to internal stakeholders and external scientific advisory boards.

Biostatistician I
Lupin Pharmaceuticals Ltd., Hyderabad, Telangana
August 2014 - May 2016

Provided statistical support for early-phase oncology clinical trials focusing on novel cancer therapeutics. Assisted in protocol development, statistical analysis plan preparation, and sample size calculations. Performed routine statistical analyses of safety and efficacy endpoints using SAS. Created and validated statistical programs in accordance with CDISC standards and regulatory guidelines. Participated in cross-functional team meetings to discuss study design, data collection, and analysis strategies. Contributed to the preparation of regulatory documents including investigator brochures and clinical study reports.

EDUCATION

Doctor of Philosophy (Ph.D.) in Biostatistics
Indian Institute of Science, Bangalore, Karnataka
Graduated: May 2014
Dissertation: "Adaptive Design Methods for Biomarker-Driven Clinical Trials in Oncology"

Master of Science (M.S.) in Statistics
Delhi University, New Delhi, Delhi
Graduated: May 2011

Bachelor of Science (B.S.) in Mathematics
Mumbai University, Mumbai, Maharashtra
Graduated: May 2009
Minor: Computer Science

TECHNICAL SKILLS

Statistical Software: SAS, R, Python, STATA
Programming Languages: SAS Programming, R, Python, Perl, C++
Clinical Trial Expertise: Protocol development, Statistical Analysis Plans, Clinical Study Reports, Phase I/II/III trial design, Adaptive designs, Interim analyses
Therapeutic Areas: Oncology, Cancer therapeutics, Immunotherapy
Genomics & Bioinformatics: NGS data analysis, RNAseq, Biomarker development, DNA analysis, Molecular profiling
Regulatory: FDA submissions, ICH guidelines, CDISC standards (SDTM, ADaM)
Data Management: Clinical data validation, Database design, Data modeling

CERTIFICATIONS

Certified Clinical Trial Professional (CCTP) - Society of Clinical Research Associates

PUBLICATIONS

Author/Co-author of 12 peer-reviewed publications in biostatistics and clinical oncology journals including Journal of Clinical Oncology, Statistics in Medicine, and Clinical Cancer Research.

PROFESSIONAL AFFILIATIONS

American Statistical Association (ASA) - Member
International Biometric Society (IBS) - Member
Society for Clinical Trials (SCT) - Member

ADDITIONAL SKILLS

Languages: English (Native), Hindi (Native), Tamil (Conversational)
Training: Experienced in training and mentoring junior statisticians and cross-functional team members on statistical methodologies and regulatory requirements