Principal Statistics

Sr. Principal Statistics Paramus, NJ 07652 Pay rate : $93 per hour on W2 Client Name: SK Life Science Experience level: Mid-senior Experience required: 6 Years Education level: Doctorate Job function: Management Industry: Pharmaceuticals Total position: 1 Skills: 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 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 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 Thank you.