Sr. Principal Statistics - SAS, ICH Guidelines, CDISC Data Structures

Job Description JOB DESCRIPTION: 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. 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 Qualifications Education: Ph.D. or MS in Statistics or Biostatistics Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Excellent knowledge of SAS computer package Excellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelines Excellent organizational skills, time management, and ability to meet established deadlines. Excellent communication and interpersonal skills to effectively interface with others Exceptional Interpersonal Skills And Problem-solving Capabilities Ability to work independently and collaboratively Ability to provide leadership for the CRO statisticians and statistical programmers Requirements PHYSICAL AND MENTAL REQUIREMENTS: Ability to multitask Adapts to change Maintain composure under pressure Ability to follow verbal or written instructions and use of effective verbal communications Adapts change, adjust change and grasps information quickly Examine and observe details