Remote Biostatistician

Job Description - Biostatistician
Job Title: Biostatistician

Location: [City, State] / Remote / Hybrid

Job Summary

We are seeking a highly analytical and detail-oriented Biostatistician to provide statistical expertise in the design, analysis, and interpretation of clinical research studies and clinical trials. The successful candidate will collaborate with cross-functional teams to develop statistical methodologies, analyze complex healthcare data, and ensure compliance with regulatory standards while supporting evidence-based decision-making.

Key Responsibilities

Design statistical analysis plans (SAPs) for clinical trials and observational studies.
Determine sample size, randomization methods, and study endpoints.
Perform statistical analyses using

SAS

, R, or other statistical software.
Analyze clinical trial data and interpret study results.
Collaborate with Clinical Data Management, Clinical Operations, Medical Writing, and Regulatory Affairs teams.
Prepare statistical reports, tables, listings, and figures (TLFs) for clinical study reports.
Support protocol development and provide statistical input during study design.
Validate statistical programming outputs and ensure data accuracy.
Assist with interim analyses, safety analyses, and final study analyses.
Contribute to regulatory submissions (FDA, EMA, PMDA, etc.) by preparing statistical documentation.
Ensure compliance with ICH-GCP, CDISC standards (SDTM, ADaM), and applicable regulatory guidelines.
Participate in publication of scientific manuscripts and conference presentations.
Required Qualifications

• Master's or Ph.D. in Biostatistics, Statistics, Mathematics, Public Health, Epidemiology, or a related quantitative field.
• 2+ years of experience as a Biostatistician in the pharmaceutical, biotechnology, CRO, or healthcare industry.
• Strong knowledge of statistical methodologies used in clinical research.
• Experience with SAS, R, or Python for statistical programming.
• Knowledge of clinical trial design and regulatory requirements.
• Familiarity with CDISC standards (SDTM, ADaM) and statistical reporting.
• Strong analytical, problem-solving, and communication skills.

Preferred Qualifications
Experience supporting Phase I-IV clinical trials.
Knowledge of Bayesian statistics, survival analysis, and longitudinal data analysis.
Experience working with FDA, EMA, or other regulatory submissions.
Familiarity with adaptive trial designs and real-world evidence (RWE) studies.
Experience in oncology, infectious diseases, cardiovascular, or other therapeutic areas.
Technical Skills
SAS

R

Python

SQL

CDISC (SDTM, ADaM)
Statistical Analysis Plans (SAP)
Sample Size Calculation
Randomization Techniques
Survival Analysis
Regression Analysis
Clinical Trial Data Analysis
TLF Generation
Microsoft Excel
Microsoft PowerPoint
Soft Skills
Strong analytical thinking
Attention to detail
Critical problem-solving
Statistical reasoning
Scientific writing
Communication and presentation skills
Cross-functional collaboration
Time management
Project management
Preferred Certifications
SAS Certified Specialist or SAS Certified Professional
Certified Clinical Research Professional (CCRP) (preferred)
Good Clinical Practice (GCP) Certification
Benefits
Competitive salary
Health, dental, and vision insurance
Paid time off
Retirement savings plan
Flexible work arrangements
Professional development and certification support
Employee wellness programs

This job description is optimized for candidates with expertise in biostatistics, statistical programming, clinical trial design, data analysis, regulatory compliance, and statistical reporting within the pharmaceutical, biotechnology, CRO, or healthcare industries.