What are the responsibilities and job description for the Sr. Principal Statistics - SAS, ICH guidelines, CDISC data structures position at Talent Search PRO?
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
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
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
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