What are the responsibilities and job description for the Principal Statistician position at Datawise Inc?
Role Summary
- Independently design, prepare, and review statistical components of clinical study protocols, including those with a high level of complexity.
- Conduct and validate sample size determinations and statistical power analyses for standard clinical trial designs.
- Create statistical analysis plans (SAPs), shells for tables/listings/figures (TLFs), and statistical reports across studies of varying complexity.
- Serve as the lead statistician for randomization activities, including preparation of randomization documentation and generation of randomization schedules.
- Participate in client-facing interactions such as study initiation meetings, timeline and resourcing discussions, bid presentations, and blinded data review meetings.
- Review and quality-check case report forms (CRFs) and data management documentation, including edit check specifications, data review plans, and data transfer specifications.
- Perform QC reviews of statistical programming outputs such as specifications, analysis datasets, and TLFs to ensure alignment with statistical analysis requirements.
- Provide guidance and mentorship to statistical programmers regarding study design concepts and implementation of statistical methods.
- Support and mentor junior or mid-level biostatisticians in statistical tasks and project-related activities.
- Ensure all deliverables and processes comply with internal quality systems, standard operating procedures/work instructions, ICH-GCP, and applicable regulatory and industry standards.
Qualifications
- Master’s degree or higher in biostatistics, statistics, mathematics, or a related scientific field preferred; a bachelor’s degree combined with equivalent relevant experience may be considered.
- Minimum of five years of hands-on experience in clinical trial biostatistics.
- Proficient in SAS/R programming, including Base SAS, SAS Macros, SAS/GRAPH, SAS/STAT, and clinical reporting workflows.
- Strong working knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
- Demonstrated understanding of and adherence to SOPs/WIs, ICH-GCP, and applicable regional and global regulatory requirements.
- Develop and review statistical analysis plans and outputs that incorporate appropriate missing data strategies, including multiple imputation.