Jane Gilbert Email & Phone Number

Brentford, Middlesex, Gb

• Working in the phase III CNS group (acute and chronic pain).• Integral part of the clinical team for a product submission to the EMEA and FDA.• Lead statistician on phase III safety studies and cancer pain studies (reviewing CRFs, presenting at investigator meetings, writing Statistical Analysis Plans, reviewing and validating datasets and tables, listings and graphs provided by programmers, reviewing Clinical Study Reports, reviewing abstracts, posters and manuscripts for publications).• Co-led preparation of datasets and outputs for ISS.• Led a team of 6 through a transition from Early Development to Late Development and supported the induction of new staff

• Worked in the Early Development group in a variety of therapeutic areas including metabolic diseases, CNS and infectious diseases.• Compound statistician for various compounds prior to their acceptance into Phase III or discontinuation.• Worked on multiple studies across several compounds and project teams.• Frequently involved in design and analysis of first-in-human, multiple dosing, food effect, bioavailabilty/ bioequivalence, drug-drug interaction and PK/PD studies.• Primary responsibilities included input into protocols, writing Statistical Analysis Plans, performing and reporting results of statistical analyses (PK , PD, safety data), reviewing outputs provided by programmers, reviewing Clinical Study Reports.• Supported the induction of new staff• Performed peer review of statistical outputs e.g. protocol input, statistical analyses

• Worked primarily in the Phase I group, but joined on a graduate rotation scheme and so experienced 3 months in the programming group and 3 months in the Phase III Statistics group as part of induction.• Worked in several therapeutic areas including Anti-fungals, PDE-5s and Stroke.• Performed sample size calculations, statistical analyses, wrote Statistical Analysis Plans, reviewed tables, graphs and listings prepared by programmers, prepared corresponding sections of the Clinical Study Report, reviewed study reports.• Supervised new graduates.

Bsc., Mathematics

Msc. (Distinction), Statistics With Applications In Medicine