DR VINCE CLINICAL RESEARCH PROPOSAL 1

Overland Park, KS Job Details 21 hours ago Qualifications Research project team leadership Statistics Statistics Biostatistics-based research Writing skills Research project technical leadership ICH guidelines Statistics research Pharmaceutical company experience CDISC standards Clinical quality assurance standards Clinical data analysis Project leadership Pharmaceutical research Data analysis software Full Job Description

JOB TITLE

Principal Biostatistician

REPORTS TO

Manager, Biometrics

DIRECT REPORTS

Not Applicable

POSITION SUMMARY

The Principal Biostatistician provides expert support for statistical planning, analysis, and interpretation in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).

KEY RESPONSIBILITIES

Participate in the protocol development, including study design, endpoints selection, sample size determination, and writing of the statistics sections Support Case Report Form (CRF) design and review relevant data management documents Develop randomization scheme, Statistical Analysis Plan (SAP), and Tables, Listings, Figures (TLF) shells Program in Statistical Analysis Software (SAS) for the TLFs and statistical analysis, or perform validation as per the Standard Operating Procedures (SOP) Conduct Quality Control (QC) review of statistical documents and SAS output Provide data interpretation for the study report Assists in the development of SOPs and guidelines for the Biostatistics department Act as biostatistics project leader, helping to manage priorities and timelines Share expertise and provide mentorship to junior staff Participate as a statistical liaison to regulatory agencies on behalf of the sponsor when necessary Other duties as required

REQUIRED QUALIFICATIONS

MS or PhD in biostatistics or related field 8+ years clinical research experience in pharmaceutical/biotech industry, with at least 3 years as a study lead Extensive knowledge of statistical methodologies in multiple therapeutic areas Ability to program statistical analyses in SAS, R, or another industry-standard software Well versed in CDISC standards and clinical data processing with emphasis on FDA/ICH requirements for data reporting Excellent verbal and written communication skills, and interpersonal skills

PREFERRED QUALIFICATIONS

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