Job Title

Summary of Position: The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings and marketing. Duties and Responsibilities: • Review protocol, understand study requirements, prepare statistical sections, design study elements including sample size calculation, analysis methods, study duration, etc. • Review CRF, database design, and edit check specs • Review study quality surveillance plan and monitor study conduct • Prepare and/or review SAP, TFL shells and specifications for variable derivation • Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables • Provide statistical and validation support for statistical analysis, analysis datasets and TFL • Review study report, manuscripts and other documents related to statistics • Work on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documents • Perform other ad-hoc statistical activities as needed • Works effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programming • Participates in monitoring CRO activities and reviewing CRO deliverables • Other duties as assigned Compensation: $93/hour We look forward to reviewing your application. We encourage everyone to apply - even if every box isn’t checked for what you are looking for or what is required. PDSINC, LLC is an Equal Opportunity Employer.