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MillenniumSoft Inc · 6 months ago

Statistician

Murray Hill, NJ

Full-time

Onsite

Mid Level

MillenniumSoft Inc is seeking a Statistician to develop and implement statistical analytic solutions to support clinical trials. The role involves developing statistical analysis plans, ensuring high-quality statistical reporting deliverables, and collaborating with division personnel to meet business goals.

Staffing & Recruiting

H1B Sponsor Likely

Responsibilities

Develop SAP with statistical analysis and reporting details including specifications for derived variables, mock-up tables, listings and figures

Program inferential statistical analyses as well as other statistical outputs as needed

Conduct exploratory analyses / graphics to support publications and other purposes

Ensure high quality deliverables for study report including the sections of detailed statistical methods

When required, prepare accurate, high quality reports of clinical trials for Data Monitoring Committees, registration of devices, publications and others

Work with division personnel to ensure delivery of high quality and timely statistical services necessary to achieve business goals

Review protocols and case report forms to ensure adequate control of design of studies

Author statistical section of protocols and provide sample size calculations

Comprehensive understanding of regulatory guidance and industry initiatives and trends as they relate to statistical methodology and regulatory submissions

Qualification

Statistical analysisStatistical analysis plan (SAP)Clinical trialsInferential statisticsRegulatory guidanceExploratory analysesHigh quality reportingSample size calculations

Required