Sr. Biostatistician II
Independently serve as clinical study statistician on multiple projects with limited supervision. Provide expertise in the design and development of study protocols and case report forms. Develop statistical analysis plans, perform statistical analyses, and interpret results. Develop SAS programs of varying complexity to analyze and report clinical data. Review programming specifications and outputs. Recognize inconsistencies and initiate resolution of data problems. Collaborate in the preparation and review of clinical study reports. Ensure adherence to regulatory and company standards.
- Perform duties of a study statistician to support clinical trials. Oversee statistical aspects in the design of clinical trials
- Provide statistical input to study protocols
- Perform sample size and power calculations
- Review CRFs and edit checks
- Develop SAP and create table, listing, and figure shells
- Review programming specifications and derived datasets
- Perform or review statistical analysis as defined in SAP
- Code complex statistical analyses as needed
- Interpret results and write sections of documents; present results
- Support program lead statisticians in preparations for interactions with regulatory agencies
- Read and understand medical/clinical literature as required by duties
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems.
- Working knowledge of FDA regulations, ICH GCP guidelines, the drug development process
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
- Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
- MS in statistics, biostatistics, or related field with 4-7 years of experience, or PhD with 2-5 years of experience
- Strong SAS programming skills
- Working knowledge of clinical trial design.
- Knowledge of FDA regulations, ICH GCP guidelines, the drug development process
- Excellent verbal and written communication skills
- Demonstrated initiative and motivation
- Good organizational skills with the ability to adapt and adjust to changing priorities
- Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
- Able to prioritize work and complete deliverables to timelines with limited supervision
- Detail and process oriented
- Oncology experience preferred
- Knowledge of R
- Simulation experience
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.