Job Title: Associate Director - Safety Statistician, Statistical Strategy & Innovation Fully remote ok - Must be based in USA in EST or CST time zones only Occasional travel to NJ Type: Direct Hire with sponsor client Base Compensation: $168000 - $252000 annually RSU, annual bonus, competitive paid time off package and health benefits offered Minimum Requirements: • PhD in Statistics or Biostatistics • 2+ years Oncology Safety Signal experience as a Statistician • Recent Oncology experience Phase II-III • Prior leadership experience Job Summary: Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety signal detection and characterization for ongoing studies and compound-level pooled clinical trial data of project(s). Act as a statistical expert consultant within the company for safety analyses. Responsibilities: • Lead for safety signal statistical handling, lead the statistical support in safety signal detection, validation, characterization, and reporting in collaboration with the safety programming team, CSPV, and epidemiology for several projects with minimal direction from the group head, and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety signal monitoring for ongoing trials. • Safety analysis methodology and standardization, develop and support statistical safety analysis methodology and standardization across the clinical development in cross-functional teams. • Builds partnerships with safety programming teams, project statistical teams, and internal cross-functional teams and external institutions to maximize available resources. • Safety working groups and initiatives represent statistics to participate (and lead if applicable) in safety signal working groups or cross-functional initiatives. Education: • PhD In statistics or Biostatistics required Experience: • Minimum 5 years of relevant experience in the pharmaceutical industry and experience as a safety statistician required. Travel: • 10% System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #DI- Ref: #568-Clinical