Senior Biostatistician

This is a fully remote position, open to applicants in California.

📋 Description

• Lead and oversee the statistical components of designated project portfolios.

• Manage and enhance statistical and programming methodologies to guarantee timely and high-quality results.

• Contribute to the statistical sections of study protocols.

• Conduct sample size calculations.

• Create randomization specifications, plans, and schedules.

• Review statistical inputs for case report forms, annotated case report forms, and database documentation.

• Write Statistical Analysis Plans for studies and project outputs.

• Investigate, develop, and implement statistical methodologies and processes.

• Develop, review, and provide insights into SDTM and ADaM dataset specifications.

• Generate table and listing shells in accordance with SAPs.

• Produce database listings for database quality assurance audits.

• Support data management and trial management teams in preparing for database lock.

• Write or oversee SAS programming and quality control for SDTM and ADaM datasets, tables, figures, and listings for clinical study reports.

• Execute statistical analyses and interpret the results.

• Collaborate with medical writers on comprehensive clinical study reports.

• Assist with regulatory submissions, including the development of ISS and ISE and responses to regulatory inquiries.

• Engage with Clinical Development Team members to enhance client satisfaction.

• Participate in Clinical Development Team and client meetings.

• Aid in the establishment of departmental infrastructure, programming standards, SAS macro and program libraries, and workload forecasts.

⛳️ Requirements

• A Master’s or Doctoral degree in statistics.

• Minimum of 5 years of experience in statistical analysis and reporting for clinical trials.

• Comprehensive understanding of clinical data management and analysis requirements according to GCPs, FDA, and ICH guidelines.

• Exceptional problem-solving, organizational, written, and verbal communication skills.

• Capability to manage several priorities with a keen attention to detail.

• Strong computer proficiency.

• Proficient in SAS programming.

• Experience in implementing CDISC standards from start to finish.

• Ability to conduct statistical analyses of clinical data and prepare written interpretations of statistical findings.

• Familiarity with core technical and regulatory requirements.

• Experience in the design, analysis, and reporting of clinical studies.

• Strong communication, collaboration, and teamwork abilities.

🏝️ Benefits

• Equal employment opportunities.

• A collaborative, diverse, and respectful workplace culture.

• Continuous opportunities for learning and professional development.