Provide statistical support for all phases of clinical development, including generating statistical analysis plans, programming for tables, listings, figures, and analysis datasets, and supporting regulatory agency requests.
Requirements
- Experience with SAS
- Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Understanding of statistical concepts and techniques, such as inference, analysis of variance, linear models, regression, survival analysis, non-parametric analysis, estimation, hypothesis testing, and statistical modeling
- Understanding of clinical trial concepts, such as randomization, hypothesis testing, estimation of treatment effects, sample size calculation, etc.
- Ability to do advanced statistical analyses, program tables and graphs, and perform data transformations.
Responsibilities
- Generate randomization schedules
- Assist with statistical methods review of the clinical study protocol under close supervision of senior biostatistician or above
- Provide and/or verify sample size calculations
- Author statistical analysis plans, including development of table, figure and listing shells
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
- Assist with quality control for statistical based SAS programs and other study documents (e.g., presentations and reports)
- Provide programming support and assist with statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
Other
- Master's degree or equivalent in Statistics, Biostatistics, or related field with 2+ years experience; PhD degree in Statistics, Biostatistics, or related field
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- Excellent problem-solving skills
- Excellent presentation skills
