BIOSTATISTICIAN / CHIEF DATA OFFICER
PERSONAL PROFILE
- 25+ years as a biostatistician and pharmaceutical science executive
EXPERTISE
Clinical Biostatistics (Phases 1-4), Adaptive Designs, Multivariate Statistics, Data Science, Safety Surveillance Studies, Post-marketing Commitment Studies, Publications, Data Safety and Monitoring Boards, Arbitration Claim Support, Scientific/Regulatory Advising and FDA Interactions, Real-world Evidence, Registries, Quality of Life, and Patient-reported Outcomes. Therapeutic areas include: rare diseases, endocrine and metabolic disorders, pulmonary diseases, allergy, cardiology, dermatology, genitourinary disorders, nephrology, oncology and hematology, CNS, virology, infectious diseases, gastrointestinal diseases, pain, addiction, and oral care. Pharma development scope includes: Rx medicines, biologics, vaccines, devices, biomarkers, OTC medicines, Rx-to-OTC switches, direct-to-OTC, medical food, and nutritionals. Has more than 150 publications.
PROFESSIONAL EXPERIENCE
Founder, Principal, and Chief Consultant, PharmaLand Consulting Group
Provides expert scientific, statistical, and strategy consulting on clinical development plans, study design, and statistical analysis plans. Serves as interim Head of Biostatistics or expert statistician. Executes data analysis in multiple therapeutic areas. Advises on adaptive designs, composite endpoints, PRO development and validation, and multivariate statistics. Regulatory consulting includes gap analysis of existing data packages, submission content and integrated submission documents, and interactions withFDA and other regulatory bodies. Supports Advisory Committee Meeting preparation and represents sponsors, as needed. Participates in vendor evaluation and acts as sponsor’s biometrics liaison with CROs.Aids Medical Affairs teams on publications planning, study design, and analysis.
Head, Biometrics and Data Management, NPS Pharma/Shire
Had operational responsibility for biometrics and served as internal consultant/subject matter expert in biostatistics. Provided strategic consulting on clinical programs, clinical development plans and study designand analysis. Supported clinical due diligence activities. Co-authored statistical/clinical evaluations of business opportunities. Supported FDA Advisory Committee meeting preparations and represented NPS at the Natpara Advisory Committee meeting. Responsible for MAAs and an NDS (Canada), advice andresponses to complex Swissmedicand Health Canada regulatory queries, key contribution to 120-and180-Day responses to EMA, and CHMP Ad-hoc Expert Meeting preparations.
Director, Biostatistics and Data Management Worldwide, GlaxoSmithKline Consumer Healthcare
Managed all biostatistics and data management activities: led department of 100+ members responsible forall centrally run Phase 1-4 clinical trials. Handled up to 200 clinical projects per year: clinical studies, claim support, regulatory inquiries/submissions, meta-analyses, and publications. Core member of GSK global(Pharma, Vaccines, Stiefeland Consumer Healthcare) External Data Transparency Initiative and co-lead of one of three work streams. Made significant contributions to many drug approvals (NDAs, sNDAs, MAAs),including first-in-class Rx-to-OTC switch programs.
Director, Biostatistics and Data Management, Target Research Associates, Inc.
Original member of core group of five individuals who built the CRO from the ground-up. Established thebiostatistics and data management department and assured quality of deliverables. Interacted with clientson strategy and operational activities. Responsible for study design, statistical sections of protocols,randomization schedules, analysis plans, study reports, and regulatory submission documents (ISSs andISEs). Provided scientific advice to clients, including top 10 pharma and medium to small biotech firms.