Top 1 Biostatistician Jobs in Overland Park Ks

Principal Biostatistician
DR VINCE CLINICAL RESEARCH PA —Overland Park, KS
- Remote
- Writing skills
- 8 years
- Analysis skills
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Principal Biostatistician
DR VINCE CLINICAL RESEARCH PA —Overland Park, KS
MS or PhD in biostatistics or related field. Participate in the protocol development, including study design, endpoints selection, sample size determination,…
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Principal Biostatistician

DR VINCE CLINICAL RESEARCH PA
Overland Park, KS

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Job Details

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 experience
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:

Not Applicable

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