Biostatistician

BiostatisticianWe 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 ResponsibilitiesDesign 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 QualificationsMaster'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 QualificationsExperience 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 SkillsSASRPythonSQLCDISC (SDTM, ADaM)Statistical Analysis Plans (SAP)Sample Size CalculationRandomization TechniquesSurvival AnalysisRegression AnalysisClinical Trial Data AnalysisTLF GenerationMicrosoft ExcelMicrosoft PowerPointSoft SkillsStrong analytical thinkingAttention to detailCritical problem-solvingStatistical reasoningScientific writingCommunication and presentation skillsCross-functional collaborationTime managementProject managementPreferred CertificationsSAS Certified Specialist or SAS Certified ProfessionalCertified Clinical Research Professional (CCRP) (preferred)Good Clinical Practice (GCP) CertificationBenefitsCompetitive salaryHealth, dental, and vision insurancePaid time offRetirement savings planFlexible work arrangementsProfessional development and certification supportEmployee wellness programsThis 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.