Sr. Principal Statistics needs 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience Sr. Principal Statistics requires: • SAS, ICH guidelines, CDISC data structures, FDA guidelines, SAP preparation, TFL shells, CRF review, database design review, edit check specifications, sample size calculation, analysis dataset validation, CRO oversight • 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 Sr. Principal Statistics duties: • 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