Margarida Geraldes

About Margarida Geraldes

Margarida Geraldes, PhD, is currently Senior Vice President at Agios Pharmaceuticals and is responsible for the strategy and oversight of the Biostatistics, Statistical Programming, Regulatory Affairs and Medical Writing functional areas. Margarida has developed deep and broad expertise in her 24 years of experience in the Pharmaceutical Industry. She has a proven success record with global regulatory submissions and approvals of medicines in several therapeutic areas with a few highlights including Reyataz® (antiretroviral), Eliquis®(cardiovascular), Zykadia® (oncology), Bavencio® (immuno-oncology), and Pyrukynd® (hemolytic anemia). Margarida has had the opportunity, over the years, to influence the strategy for clinical development plans, regulatory submissions and outcomes, and present, in-person, to Health Authorities globally, including FDA, PMDA, EMA, MHRA, BfArM, NoMA, DKMA, MPA, ANSM, AEMPS, Health Canada, TGA. She helped shape the ICH E14 guideline as an active member of the PhRMA QT Statistical Expert Team from its inception, was involved in the FDA/PhRMA non-proportional hazards working group and presented to CHMP as an industry representative in a multi-pharmaceutical company/CHMP discussion on statistical and clinical methodological issues associated with the evaluation of immuno-oncology drugs. Margarida holds a PhD in Statistics from Michigan State University.

Experience

1. Senior Vice President, Head of Biometrics, Regulatory Affairs & Medical Writing

   Agios Pharmaceuticals

   Feb 2023 — Present · Cambridge, MA, US

Education

• Michigan State University

  PhD, Statistics

  1994 — 1999

Skills

• Biotechnology
• Biostatistics
• Clinical Research
• Edc
• Therapeutic Areas
• Ctms
• Sas
• Clinical Trials
• Statistical Programming
• Clinical Data Management
• Drug Development
• Gcp
• Clinical Development
• Cdisc
• Regulatory Submissions
• Oncology
• Protocol
• Survival Analysis
• CRO
• Clinical Study Design
• Sas Programming
• Validation