Datawise Inc · 13 hours ago
Principal Statistician
New Jersey, United States
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expDatawise Inc is seeking a Principal Statistician to lead the design and execution of statistical components for clinical studies. The role involves creating statistical analysis plans, conducting sample size determinations, and mentoring junior biostatisticians while ensuring compliance with regulatory standards.
Biotechnology
Responsibilities
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
Qualification
Required
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
Company
Datawise Inc
Drawing from years of clinical research expertise, our proficient professionals specialize in top-tier services including clinical study design, data management, statistical analysis, and SAS/statistical programming.
11-50 employees
H1B Sponsorship
Datawise Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Early StageCompany data provided by crunchbase