David A. Lombardi

Director Biostatistics @Navitas Data Sciences

Director Biostatistics (2021-current), Senior Biostatistician (20••••21) •Maintain full-scope of Lead Biostatistical responsibility for BioPharma based Phase I, II, Clinical Trials and Registry Studies, including coordinating and monitoring assignments of CROs • Full Biostatistical support and responsibility for activities and deliverables for Clinical Development, Regulatory and Medical Affairs, including peer-reviewed publications, scientific presentations, drug-related brochures, and regulator communications • Provide RWE and Epidemiological guidance and translation of study designs into algorithms to extract, analyze and report secondary data for Non-Interventional Studies (NIS), including electronic health records (EHR) and personal digital device data • Develop Statistical Analysis Plan (SAP), tables, listings and figures using SAS, AdAMs and CDISC standards to create/maintain analyses according to Sponsor and FDA specifications • Provide Clinical Protocol and CRF guidance including selection of appropriate statistical methods and study designs, endpoint definition, randomization and sample sizes estimation • Experienced in leading statistical programming activities such as ADaM programming, Tables, listings, patient profiles, IB, DSUR, PSUR, Integrated Summary of Safety, Annual Safety Reports and/or other safety analysis. • Writing and reviewing CSR, peer-reviewed manuscripts, and other statistical reports. • Provide statistical guidance for other Biostatisticians, and represent Biostatistics in communication with Sponsors with the FDA and at other regulatory meetings. • Execute quality assurance procedures on all work produced for completion to specification. • Ensure that all Biostatistical methods comply with regulations, guidance and standards published by FDA, ICH, EMA and other regulatory groups in project area. • Proposal development and business development activities as required. • Excellent statistical programming skills in both SAS and R.