AnalysisOversightStatisticalProgrammingLeadManager

Bachelor's Degree and Seven Years’ Experience OR Masters' Degree and Five Years’ Experience, Minimum 2 years leading studies in Virology, Oncology, or Inflammation Therapeutic Area, Mature statistical knowledge and expertise in the development of ADaM and TFLs and dependent tasks/activities, Proven track record in delivering high quality statistical programming datasets and outputs, Ability to collaborate and work effectively with global team members and build relationships, Expertise working in global teams, across various time-zones to achieve clinical trial milestones, Remains current and has deep knowledge of GCP, ICH guidelines, and regulatory requirements, specifically as it relates to quality oversight, quality assurance, and risk management, Ability to problem-solve using data-driven approaches to help determine the best path forward, Excellent customer-focus with proven track-record in building relationships through superlative communication and writing skills, Superior skills in coaching and mentoring staff of varying skillsets and respectful of cultural differences especially communication styles, Results-oriented and able to work closely with others through great collaboration to resolve challenges, bottlenecks, or risks, Ability to motivate large diverse teams to achieve a common set of goals, experience in data analysis and demonstrated critical thinking skills, Strong programming experience in non-compartmental Pharmacokinetics (PK) analysis for various study designs, Oversee and guide the development of statistical programs for TQT, cQT, pharmacokinetics (PK), and pharmacodynamics (PD) analysis, ensuring adherence to study protocols and regulatory submissions, Able to lead and mentor effective cross functional teams and keep programming team promptly informed of all study activities