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.
