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.
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.
- bility to work independently and problem-solve.
- bility to provide leadership for the CRO statisticians and statistical programmers.
