Senior Biostatistician: Lead Clinical Trials & SAS

Therapeutics,-Inc.; San Diego (CA); Vor Ort; USD 120.000 - 140.000; Vollzeit

Zusammenfassung

Therapeutics, Inc. in San Diego seeks a Sr. Biostatistician to lead statistical activities across multiple clinical programs. You will design analyses, develop SAPs, and supervise SAS programming to ensure CDISC-compliant data and timely study reports.

Ideal candidates have a Master’s or PhD in statistics with 5+ years in clinical trials, deep knowledge of GCP/FDA/ICH guidelines, and strong collaboration with data management, medical writing, and project teams.

Qualifikationen

• Master's or Doctoral degree in statistics with 5+ years of clinical trial experience.
• Strong knowledge of GCP, FDA and ICH guidelines.
• Excellent problem solving, organizational and communication skills.
• Proficient SAS programming with end-to-end CDISC standard implementations.
• Ability to write SAPs and interpret results for CSR publications.

Aufgaben

• Leadership and project management of statistical aspects of assigned project portfolio.
• Develop and review SDTM/ADaM datasets and SAPs; ensure regulatory readiness.
• Write and supervise SAS programming for tables, figures and listings.
• Collaborate with data management, medical writing, and trial teams.
• Support regulatory submissions and integrated summaries of safety/efficacy.

Kenntnisse

Statistical analysis

Project leadership

GCP/FDA/ICH knowledge

SAS programming

Data interpretation

Collaboration

Ausbildung

Master's or PhD in Statistics

Tools

SAS

CDISC SDTM/ADaM

Jobbeschreibung

Therapeutics, Inc. in San Diego seeks a Sr. Biostatistician to lead statistical activities across multiple clinical programs. You will design analyses, develop SAPs, and supervise SAS programming to ensure CDISC-compliant data and timely study reports.

Ideal candidates have a Master’s or PhD in statistics with 5+ years in clinical trials, deep knowledge of GCP/FDA/ICH guidelines, and strong collaboration with data management, medical writing, and project teams.