Veloxis Pharmaceuticals, Lead Biostatistician• Provided biostatistical guidance, including sample size calculations, study design support, analysis methodology, SAP reviews, TFL reviews, SAS programming, DM spec reviews, and FDA response document text contribution as Veloxis only Biostatistician working part-time (20hr/wk) for Veloxis.Cyclo Therapeutics, Biostatistical Contracting Consultant• Provided Biostatistical guidance and services, including FDA meeting support (briefing package contribution and meeting), sample size calculations, study design support, analysis methodology.PharmArray, Biostatistical Contracting Consultant• Provided Biostatistical services, including SAP review and DM spec reviews for a Biotech client

(Left due to Restructuring / Layoff)Head of Biometrics (Biostats, Programming, CPK, DM) for a small CRO

Led US growth for Evidence Generation group, including as Biostat project lead

Managed Worldwide's Statisticians and resource planning, and provided senior level oversight for their projects. Also provided Stats budgeting information for our contract bids, and attended bid defense meetings. Provided regulatory meeting support, study design and statistical guidance and consulting for sponsors.

(Left due to Restructuring / Layoff)• Progressed from Statistician to Principal Statistician to Statistics Manager• Project leading statistician for numerous projects in Neurosciences area• Involved in drug approval and reimbursement process for multiple drugs/indications both in US and Europe• Collaborated with cross-functional project team for a pilot joint meeting to discuss the development plan for a rare disease indication with the EMA and individual European payer agencies• Have met with FDA and EMA via both F2F and teleconference to discuss study designs and submission requirements• Presented study results to key study investigators, and internal upper management• Managed both internal and external SAS programmers on multiple projects, and multiple studies at once• Primarily work on projects with Phase II through Phase IV studies, and some experience with Phase I studies• Evaluated external company compounds for GSK via due diligence process• Acted as Independent Data Monitoring Committee statistician for studies• Managed study budgets for statistical and programming expenses, and provided programming resource estimates• Wrote statistical analysis plans, and statistical sections of protocols and clinical study reports• Reviewed and provided input on clinical development plans, product profiles, and therapeutic standards• Presented description of statistical and endpoint sections of protocols at investigator meetings• Performed statistical analyses• Provided statistical consultation• Delivered analysis TLFs for clinical study reports and other purposes using SAS• Collaborated with multiple cross-functional disciplines to ensure study and/or project deliverables are met• Handled data aggregation initiative for safety data across multiple in-house drugs for the same indication• Served on project teams for in-licensed drugs jointly developed with another company• Contributed to numerous abstracts, manuscripts, and scientific posters

Medium sized contract research organization for the pharmaceutical industry.Biostatistician• Led a group of biostatisticians for an epilepsy project consisting of multiple studies• Was the primary statistician for single studies in various disease areas• Performed sample size calculations• Wrote statistical analysis plans• Performed statistical analyses• Created analysis tables, listings and figures for clinical study reports using SAS