The Statistician develops or assists in the development of protocol designs, data analysis and reporting, and regulatory submission in collaboration with internal clinical study team and external stakeholders including business partners, CROs. Statistician may need to do statistical programming work if required.
The Statistician is accountable to:
- Operate in collaboration with study personnel to provide input to study protocol, perform sample size calculation, develop randomization schedule, write/review Reporting Analysis Plan, and write/review Statistical Analysis Report.
- Participate in peer-review of work products from other statistical colleagues.
- Oversee the process and quality of statistical work contracted out to a CRO or research collaborator.
- Collaborate with data management in the planning and implementation of data quality assurance plans.
- Perform 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).
- Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology.
- Knowledge of RECIST.
- Knowledge of statistical theories and application.
- Knowledge of CDISC.
- Knowledge of statistical tools such as SAS, nQuery, PASS, East.
- Educated to at least master level in Statistics, Math or equivalent field of study.
- At least 2-3 years’ experience in pharmaceutical company or Clinical Research Organization (CRO) as a biostatistician or programmer.
- At least 1 year experience in the SAS programming.
- Positive working attitude.
- Working experience in oncology projects.
- Self-management skills with a focus on deliverables.