Skip to content

Curriculum Vitae

Positions, education, leadership, and service.

Chennai, India · Google Scholar · LinkedIn · PDF

Profile

Biostatistics leader pairing hands-on industry development and FDA regulatory experience across the drug-development lifecycle with a strong academic and methodological foundation. Currently Senior Manager, Biostatistics at Pfizer (Associate Director–equivalent) and a member of the Data Science & Analytics India leadership team, leading a team of statisticians across global Oncology and Inflammation & Immunology programs. Former FDA Oncology Center of Excellence primary reviewer with hands-on NDA/BLA experience, product-labelling negotiation, and pioneering use of real-world evidence and external-control cohorts.

Experience

Seven roles on one time axis from 2011 to now: Cytel in 2011, the University of Florida from 2012 to 2017, the University of Northern Colorado to 2019, Nemours in 2019, the FDA from 2020 to 2022, and Pfizer since 2022.

Jun 2024 – present Senior Manager, Biostatistics — Pfizer Healthcare India Pvt. Ltd., Chennai, India

• Associate Director–equivalent statistical leader on the Data Science & Analytics India leadership team, shaping statistical strategy across global Inflammation & Immunology development programs.
• Lead and develop a team of statisticians — building talent, strengthening statistical capability, and fostering a culture of scientific excellence.
• Build enterprise capability in real-world evidence and target trial emulation, partnering with Statistics leadership to advance next-generation evidence generation.
• Advance modern quantitative methods across programs, including endpoint consolidation, real-time trial monitoring, and reproducible quantitative science.

May 2022 – May 2024 Manager, Biostatistics — Pfizer Healthcare India Pvt. Ltd., Chennai, India

• Trial-statistician leadership across Inflammation & Immunology programs spanning pediatric ulcerative colitis and inflammatory bowel disease, with medical-affairs support and priority programs in atopic dermatitis, asthma, and COPD — from study design through regulatory deliverables.
• Oncology statistical leadership on targeted-therapy programs across non-small cell lung cancer and melanoma, spanning protocol design, analysis planning, and submission-supporting deliverables.

Feb 2020 – Apr 2022 Mathematical Statistician (Primary Reviewer) — U.S. Food and Drug Administration, Oncology Center of Excellence, Silver Spring, MD, USA

• Primary statistical reviewer for NDA, BLA, and IND submissions across multiple oncology indications, delivering independent assessments that informed regulatory decisions and product labelling.
• Reviewed applications spanning gastric and gastroesophageal cancers, cholangiocarcinoma, and additional solid-tumor indications, as well as an oncology biosimilar and a supportive-care (otoprotection) program.
• Led sponsor–agency interactions and labelling negotiations, translating statistical findings into clear regulatory positions.
• Contributed to one of the FDA’s early evaluations of real-world evidence and external-control cohorts through review of a pediatric neuroblastoma program.

Aug 2019 – Jan 2020 Biostatistician — Nemours Children’s Health System, Jacksonville, FL, USA

• Led end-to-end statistical strategy for investigator-initiated pediatric studies across multiple therapeutic areas — concept and design through analysis, interpretation, and publication.

Aug 2017 – Jul 2019 Assistant Professor of Statistics (tenure-track) — University of Northern Colorado, Greeley, CO, USA

• Taught graduate and undergraduate statistics, mentored students, and led applied and methodological research.
• Served as statistical consultant on cross-disciplinary research collaborations across the university.

Aug 2012 – Aug 2017 Graduate Assistant & Instructor — University of Florida, Department of Statistics, Gainesville, FL, USA

• Instructor, teaching assistant, and statistical consultant while completing PhD research.

Jun 2011 – Apr 2012 Statistician — Cytel Statistical Software & Services Pvt. Ltd., Pune, India

• Supported early-stage sponsor studies through statistical programming, analysis, and study-support activities.

Education

2012 – 2017 PhD, Statistics — University of Florida

2009 – 2011 MSc, Statistics — University of Calcutta

2006 – 2009 BSc, Statistics — University of Calcutta

2025 Leadership Development Programme — IIM Ahmedabad (for Pfizer)

Professional leadership & scientific service

• Scientific Committee Member — International Indian Statistical Association (IISA)
• Council Member, Biostatistics Council — Indian Society for Clinical Research (ISCR)
• Mentor, Pfizer statistics internship program
• Biostatistics workshops — Loyola College and SSKM Hospital, Kolkata

Selected presentations

• IISA Annual Conference — 2024, 2022
• Novartis Sankhya — 2023
• International Triennial Calcutta Symposium on Probability & Statistics — 2018, 2015
• ASA Joint Statistical Meetings (JSM) — 2017

Research focus

Much of my recent work sits in two places: using target trial emulation to bring observational data to bear on questions trials answer slowly or not at all, and endpoint and estimand strategy — deciding what a trial should measure before arguing about how to analyse it.

Publications

15 peer-reviewed journal articles · 315 citations (as of July 2026) · Google Scholar

Fifteen papers by year from 2017 to 2026, one dot each; the first-authored paper, in 2019, is circled.

2026

1. Dubinsky MC, Cohen ER, Irving PM, … Bhattacharjee A, et al. Bowel urgency in ulcerative colitis is associated with clinical endpoints, health-related quality of life, and biomarkers: data from the etrasimod ELEVATE UC 52 trial. Crohn’s & Colitis 360. 2026;otag072. doi

2. Makgoeng SB, Gamalo M, Russo LJ, Pradhan V, Bhattacharjee A, Bhosale N. Data-driven trial design: use of target trial emulation to evaluate eligibility criteria in asthma and COPD. Frontiers in Medicine. 2026;13:1863026. doi

2025

3. Armuzzi A, Rubin DT, Schreiber S, … Bhattacharjee A, et al. Health-related quality of life outcomes with etrasimod treatment in patients with ulcerative colitis: a post hoc analysis of data from ELEVATE UC 52 and ELEVATE UC 12. Inflammatory Bowel Diseases. 2025;31(6):1583–1594. doi

4. Jairath V, Rubin DT, Verstockt B, … Bhattacharjee A, et al. The effect of etrasimod on fecal calprotectin and high-sensitivity C-reactive protein: results from the ELEVATE UC clinical program. Inflammatory Bowel Diseases. 2025;31(4):923–934. doi

5. Magro F, Peyrin-Biroulet L, Sands BE, … Bhattacharjee A, et al. Endoscopic, histologic, and composite endpoints in patients with ulcerative colitis treated with etrasimod. Clinical Gastroenterology and Hepatology. 2025;23(2):341–350. doi

6. Afzali A, Regueiro M, Yarur AJ, … Bhattacharjee A, et al. Concomitant use of etrasimod with opioids or antidepressants in patients with ulcerative colitis — a safety analysis. United European Gastroenterology Journal. 2025;13(5):719–727. doi

2024

7. Regueiro M, Siegmund B, Yarur AJ, … Bhattacharjee A, et al. Etrasimod for the treatment of ulcerative colitis: analysis of infection events from the ELEVATE UC clinical programme. Journal of Crohn’s and Colitis. 2024;18(10):1596–1605. doi

2021 and earlier

8. Imerci A, Rogers KJ, Bhattacharjee A, Bowen JR, Thacker MM. Risk factors for failure of Pavlik harness treatment in infants with dislocated hips evaluated by dynamic sonography. Journal of Pediatric Orthopaedics. 2021;41(6):e386–e391. doi

9. Chatterjee N, Nair PKR, Nair VD, Viswanath S, Bhattacharjee A. Depth-wise distribution of soil-carbon stock in aggregate-sized fractions under shaded-perennial agroforestry systems in the Western Ghats of Karnataka, India. Agroforestry Systems. 2020;94(2):341–358. doi

10. Alharash H, Hossain MJ, Bhattacharjee A, Levenbrown Y. Use of pulse contour technology for continuous blood pressure monitoring in pediatric patients. Blood Pressure Monitoring. 2020;25(5):278–284. doi

11. Chatterjee N, Nair PKR, Nair VD, Bhattacharjee A, et al. Do coffee agroforestry systems always improve soil carbon stocks deeper in the soil? A case study from Turrialba, Costa Rica. Forests. 2019;11(1):49. doi

12. Ying W, Bhattacharjee A, Wu SS. Effect of laser acupuncture on mitigating anxiety in acute stressed horses: a randomized, controlled study. American Journal of Traditional Chinese Veterinary Medicine. 2019;14(1).

13. Bhattacharjee A, Ghosh M. Bias-corrected empirical Bayes confidence intervals for the selected mean. Communications in Statistics — Theory and Methods. 2019;48(3):583–595. doi

14. Ahn H, Woods AJ, Kunik ME, … Bhattacharjee A, et al. Efficacy of transcranial direct current stimulation over primary motor cortex and contralateral supraorbital area on clinical pain severity and mobility performance in persons with knee osteoarthritis: a randomized, sham-controlled pilot study. Brain Stimulation. 2017;10(5):902–909. doi

15. Wu SS, Chen S, Bhattacharjee A, He Y. Collusion-resistant multi-matrix masking for privacy-preserving data collection. 2017 IEEE 3rd International Conference on Big Data Security on Cloud (BigDataSecurity). 2017:1–7. doi

Last tended 9 October 2026.