The company is looking for a lead biostatistician to manage biostatistics efforts for projects, including protocol review, statistical analysis plan writing, SAS programming, and resource management within the department. They also need someone to provide technical expertise for programming standards and procedures.
Requirements
- Experience with SAS
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Familiarity with most complex statistical methods that apply to Phase I-IV clinical trials
- Experience with oncology and rare disease
- Experience with submissions
Responsibilities
- Write and/or review statistical analysis plans
- Provide sample size calculations
- Provide randomization schedules and serve as the unblinded statistician
- Program and/or QC CDISC datasets, tables, and figures using SAS
- Provide input to and/or QC clinical documents, including CRFs, protocols and CSRs
- Perform the senior level review on a final analysis package delivery of outputs
- Provide statistical consultative support
Other
- Manage employees, including senior level, within the Biostatistics and Statistical Programming functional areas
- Assist with development and maintenance of departmental procedures and standards
- Assist with project forecasting and resourcing needs through a combination of internal and external resources
- Hire, train, and provide development opportunities for Biostatisticians and Statistical Programmers
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
