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Biostatistician

Alpha Stats -
Piscataway, NJ

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Job Details

Qualifications

Clinical study protocols and reports
Biostatistics-based research
Medical statistical report preparation
SAS
Pharmaceutical regulatory compliance
Writing skills
SAS language
Statistics research
Pharmaceutical company experience
Quality control
Clinical program data analysis
CDISC standards
Clinical research reports
Clinical data analysis
Ad-hoc reporting
Standard operating procedures (SOPs)

Full Job Description

We are looking for a highly-motivated Biostatistician on W2 or 1099 basis. This position provides statistical support for all phases of clinical development. Specific responsibilities include writing statistical analysis plans and statistical sections of protocols, and developing SAS programs for inferential analysis.

JOB REQUIREMENTS

Write Statistical Analysis Plans and develop table and listing shells
Provide sample size calculations
Quality control of randomization schedules
Provide input into development of case report forms (CRFs)
Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials
Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
Perform quality control for SAS programs and other study documents
Provide statistical analysis and reports to Data Monitoring Committees (DMCs)
Review outputs across programs to ensure consistency
Prepare statistical sections of clinical study reports
Complies with company SOPs and regulatory guidance

EDUCATION AND EXPERIENCE REQUIREMENTS:

PhD. in statistics or biostatistics with at least 3 years or MS in statistics or biostatistics with at least 5 years experience in pharmaceutical industry
Knowledge of industry standards, such as the ICH guidelines, 21 CFR Part 11, CDISC data structures, and FDA guidelines

SKILL AND OTHER REQUIREMENTS:

Strong in SAS programming
Excellent organizational skills, time management, ability to coordinate workload and meet established deadlines, and a good team player
Excellent communication and interpersonal skills to effectively interface with others

POSITION TITLE

Senior Biostatistician or Contractor

DURATION

12+ months for contractor

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