Senior Principal Statistical Programmer, Paramus

Senior Manager in Statistics

The Senior Manager in Statistics is responsible for performing statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings, and marketing. Responsibilities include: Reviewing protocol, understanding study requirements, preparing statistical sections, designing study elements including sample size calculation, analysis methods, study duration, etc.Reviewing CRF, database design, and edit check specs. Reviewing study quality surveillance plan and monitoring study conduct. Preparing and/or reviewing SAP, TFL shells, and specifications for variable derivation. Working closely with Statistical Programmers and Clinical Data Manager to identify data quality issues for key efficacy and safety variables.Providing statistical and validation support for statistical analysis, analysis datasets, and TFL. Reviewing study report, manuscripts, and other documents related to statistics. Working on responses to health authorities and executing new analysis required for responses, reviewing statistical inputs for regulatory documents.Performing other ad-hoc statistical activities as needed. Working effectively with cross-functional groups, study team, and vendors. Proactively controlling and monitoring timelines related to statistics and statistical programming. Participating in monitoring CRO activities and reviewing CRO deliverables.Requirements include: 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. Ability to work independently and problem-solve. Ability to provide leadership for the CRO statisticians and statistical programmers.