Biostatistician

Summary

OVA.Work is seeking a highly analytical and detail-oriented Biostatistician to provide statistical expertise in clinical research studies and trials. The successful candidate will collaborate with cross-functional teams to develop methodologies, analyze healthcare data, and ensure regulatory compliance while supporting evidence-based decision-making.

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

Skills

• 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
• 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
• SAS Certified Specialist or SAS Certified Professional
• Certified Clinical Research Professional (CCRP) (preferred)
• Good Clinical Practice (GCP) Certification

Qualifications

Must Haves

• 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

Nice to Haves

• 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
• SAS Certified Specialist or SAS Certified Professional
• Certified Clinical Research Professional (CCRP) (preferred)
• Good Clinical Practice (GCP) Certification

Benefits

• Health, dental, and vision insurance
• Paid time off
• Retirement savings plan
• Flexible work arrangements
• Professional development and certification support
• Employee wellness programs