Senior Principal Statistics

• 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