Mac received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology and has been with Janssen for 18 years, and in industry for over 20. He has been involved with Lupus research since joining the organization with focus areas in late development immunology and clinical trial safety. He has been heavily involved in pharmacovigilance, signal detection and safety data visualization for most of his career, including membership in several multi-disciplinary industry/regulatory working groups. Prior to joining Janssen, Mac developed a safety surveillance and signal detection team at Cephalon. Currently he is the Clinical Team Statistical Lead for across 11 indications and several therapeutic areas. Outside of clinical research, Mac is involved on many internal teams focused on safety statistics and leads process development initiatives (e.g implementation of the ASAP process) and also continues to represent the organization on many external safety working groups.