The Statistician/Senior 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.
The Statistician/Senior 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
- Assist with or be responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations
- Respond to statistical queries from other functional areas (e.g. medical, regulatory) and to interact with regulators as required.
- Collaborate with data management in the planning and implementation of data quality assurance plans.
- Provide tailored statistics education to less experienced statisticians or other groups if required
- 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
- Perform statistical programming if required
- Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology
- Ability to negotiate and strategically influence other team members
- Knowledge of statistical theories and application
- Knowledge of clinical trial design elements and potential issues
- Knowledge of statistical tools such as SAS, nQuery, PASS, East
- Knowledge of Industry SOPs and regulatory requirements relating to statistics and data quality
- Educated to at least master level in Statistics, Math or equivalent field of study
- At least 3-4 years experience in a multinational pharmaceutical company or Clinical Research Organization (CRO) as a biostatistician
- Proficient in the SAS programming language
- Positive working attitude
- Experience in early phase drug development, especially in oncology area
- Application of advanced theory and techniques in clinical development
- Self-management skills with a focus on deliverables