Senior Principal Statistical Programmer

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 identifying 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
• Participate in monitoring CRO activities and reviewing CRO deliverables

Requirements

• 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