Biostatistician
BioPhase Solutions specializes in recruiting top talented professionals for the San Diego County Scientific community. We are currently looking for a REMOTE 1099 or W2 Biostatistician to work for a leading San Diego clinical-stage biotech company.
Responsibilities
• Develop and review Statistical Analysis Plans (SAPs) for clinical studies.
• Perform statistical analyses and provide interpretation of clinical and safety data.
• Create specifications for analysis datasets, tables, listings, and figures (TLFs).
• Review and quality control statistical programming outputs to ensure accuracy and regulatory compliance.
• Partner with Clinical Operations, Data Management, Medical Writing, Regulatory Affairs, and external vendors to support study execution and reporting.
• Identify data trends, inconsistencies, and analytical issues and recommend solutions.
• Support preparation of study reports, regulatory submissions, and scientific publications.
Qualifications
• MS with 10+ years or PhD with 7+ years of experience in Biostatistics, Statistics, or a related quantitative discipline.
• Experience supporting clinical development programs within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial methodology, statistical principles, and regulatory requirements.
• Experience reviewing and quality controlling statistical analyses, datasets, and programming deliverables.
• Strong communication skills with the ability to collaborate across multidisciplinary teams.
• Ability to work independently in a fast-paced environment while managing multiple priorities.
• Advanced programming proficiency in SAS and/or R is required. Candidates without strong hands-on SAS or R programming experience will not be considered.
Preferred Experience
• Experience supporting Phase I–III clinical studies.
• Prior involvement with regulatory submissions and health authority deliverables.
• Experience working with CROs and external statistical programming teams.
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Responsibilities
• Develop and review Statistical Analysis Plans (SAPs) for clinical studies.
• Perform statistical analyses and provide interpretation of clinical and safety data.
• Create specifications for analysis datasets, tables, listings, and figures (TLFs).
• Review and quality control statistical programming outputs to ensure accuracy and regulatory compliance.
• Partner with Clinical Operations, Data Management, Medical Writing, Regulatory Affairs, and external vendors to support study execution and reporting.
• Identify data trends, inconsistencies, and analytical issues and recommend solutions.
• Support preparation of study reports, regulatory submissions, and scientific publications.
Qualifications
• MS with 10+ years or PhD with 7+ years of experience in Biostatistics, Statistics, or a related quantitative discipline.
• Experience supporting clinical development programs within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial methodology, statistical principles, and regulatory requirements.
• Experience reviewing and quality controlling statistical analyses, datasets, and programming deliverables.
• Strong communication skills with the ability to collaborate across multidisciplinary teams.
• Ability to work independently in a fast-paced environment while managing multiple priorities.
• Advanced programming proficiency in SAS and/or R is required. Candidates without strong hands-on SAS or R programming experience will not be considered.
Preferred Experience
• Experience supporting Phase I–III clinical studies.
• Prior involvement with regulatory submissions and health authority deliverables.
• Experience working with CROs and external statistical programming teams.
Apply tot his job
Apply To this Job