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.