Sr. Principal Statistics [1420]

ABOUT:Contract: 5+ monthsLocation: Paramus, NJ 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 specsReview study quality surveillance plan and monitor study conductPrepare and/or review SAP, TFL shells and specifications for variable derivationWork closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variablesProvide statistical and validation support for statistical analysis, analysis datasets and TFL Review study report, manuscripts and other documents related to statisticsWork on responses to health authorities and execute new analysis required for responses, review statistical inputs for regulatory documentsPerform other ad-hoc statistical activities as neededWorks effectively with cross functional groups, study team, and vendors. Proactively control and monitor timelines related to statistics and statistical programmingParticipates in monitoring CRO activities and reviewing CRO deliverablesOther duties as assigned QUALIFICATIONS:Education: Ph.D. or MS in Statistics or BiostatisticsMinimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experienceExcellent knowledge of SAS computer packageExcellent knowledge of industry standards, such as the ICH guidelines, CDISC data structures and FDA guidelinesExcellent organizational skills, time management, and ability to meet established deadlines.Excellent communication and interpersonal skills to effectively interface with othersExceptional interpersonal skills and problem-solving capabilitiesAbility to work independently and collaborativelyAbility to provide leadership for the CRO statisticians and statistical programmers PHYSICAL AND MENTAL REQUIREMENTS:Ability to multitaskAdapts to changeMaintain composure under pressureAbility to follow verbal or written instructions and use of effective verbal communicationsAdapts change, adjust change and grasps information quicklyExamine and observe details