4+ years (Ph.D) or 6+ years (MS) of experience in Pharmaceutical/CRO industry
Proficient in SAS software
Strong understanding of ICH guidelines and CDISC data structures
Excellent organizational and time management skills
Strong communication and interpersonal abilities
Ability to lead CRO statisticians and programmers
Responsibilities
Review protocols and prepare statistical sections
Design study elements including sample size calculations and analysis methods
Monitor study quality and conduct
Prepare and review SAP, TFL shells, and variable derivation specs
Identify data quality issues with Statistical Programmers and Clinical Data Manager
Provide statistical support for analysis datasets and TFL
Review study reports, manuscripts, and regulatory documents
Engage in responses to health authorities and new analyses as required
Oversee CRO activities and review deliverables
Benefits
Comprehensive health insurance
Retirement plan with company match
Generous paid time off policy
Flexible work schedule
Professional development opportunities
Full Job Description
Summary of Position: 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.
Duties and 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
Must have:
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
bility to work independently and problem-solve
bility to provide leadership for the CRO statisticians and statistical programmers
