Contractor Senior/Principal Statistician - Remote
Remote / Online - Candidates ideally in
Woodbridge Township, Middlesex County, New Jersey, 07095, USA
Listed on 2026-08-04
Woodbridge Township, Middlesex County, New Jersey, 07095, USA
Listing for:
Datawise Inc
Contract, Remote/Work from Home
position Listed on 2026-08-04
Job specializations:
-
IT/Tech
Data Scientist, Data Analyst, Information Security & Data Protection
Job Description & How to Apply Below
- 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.
- Master’s degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific field preferred, with hands‑on experience supporting FDA New Drug Application (NDA) submissions; a bachelor’s degree with equivalent relevant experience will also be considered.
- 5+ years of hands‑on experience in clinical trial biostatistics.
- Experiences in rare disease or neuromuscular area are preferred.
- Strong proficiency in SAS and R programming, including Base SAS, SAS Macros, SAS/GRAPH, SAS/STAT, and end‑to‑end clinical reporting workflows.
- Solid working knowledge of CDISC standards, including CDASH, SDTM, and ADaM.
- Demonstrated experience in developing and reviewing Statistical Analysis Plans (SAPs) and outputs, incorporating appropriate missing data handling methods such as multiple imputation.
Position Requirements
10+ Years
work experience
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