The Senior statistician is responsible for all statistical aspects of a clinical development project of one compound, from early clinical development, to registration and marketed product support.
- Serves as statistical representative in the cross-functional teams for the strategic planning, execution for product development and trial design.
- Involved in research activities for innovative statistical methods and applications in clinical trial development.
- Prepare statistical related sections in clinical trial protocols, clinical trial reports, submission documents, and publications.
- Develops statistical analysis plans (SAP) or oversees SAP development.
- Oversees trial conducts from statistical perspective.
- Assist with or be responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations.
- Oversees process and quality of statistical work contracted out to a CRO or research collaborator.
- Performing statistical programming to validate the results produced by CRO or to meet internal need of data analysis (e.g. for publication, or for optimizing assumptions for study design), when needed.
- Mentors junior colleagues in techniques, processes.
- PhD degree in statistics/biostatistics or related discipline with a minimum of 2 years work experience as statistician in pharma/CRO, or a Master’s degree with a minimum of 4 years work experience as statistician in pharma/CRO.
- Thorough knowledge of statistical methodology, pharmaceutical research and development strategies and execution, GCP and regulatory guidelines.
- Good project management skills
- Excellent communication and presentation skills to interact with authorities and external bodies (specialists as well as non-specialists) on statistical-methodological issues
- Strong time management and prioritization skills
- Knowledge of statistical tools such as SAS, nQuery, PASS, East
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
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