Senior Biostatistician

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

📋 Description

• Lead and manage the statistical components of the assigned project portfolio.

• Supervise and enhance statistical and programming methods to ensure high-quality results are delivered on schedule.

• Assist in drafting the statistical sections of study protocols.

• Conduct sample size estimations and develop randomization specifications.

• Review and offer statistical insights for the design of case report forms.

• Write Statistical Analysis Plans (SAPs).

• Research, develop, and apply various statistical methodologies and processes.

• Create and/or assess specifications for SDTM and ADaM datasets.

• Prepare table and listing shells according to the SAP.

• Produce database listings for quality assurance audits.

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

• Draft and/or oversee SAS programming and quality control to produce SDTM and ADaM datasets.

• Conduct statistical analyses of data and interpret the findings.

• Collaborate with medical writers to generate integrated clinical study reports.

• Contribute to regulatory submissions, including the preparation of Integrated Summaries of Safety (ISS) and Efficacy (ISE).

• Engage with members of the Clinical Development Team.

• Attend Clinical Development Team meetings and client discussions.

• Contribute to the development of departmental infrastructure and uphold programming standards.

⛳️ Requirements

• A Master’s or Doctoral degree in statistics.

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

• In-depth knowledge of Good Clinical Practices (GCPs), FDA, and ICH guidelines.

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

• Capability to handle multiple priorities with keen attention to detail.

• Strong computer skills and proficiency in SAS programming.

• Familiarity with essential technical and regulatory requirements.

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

• Excellent communication, collaboration, and teamwork skills.

🏝️ Benefits

• Opportunities for professional development and career advancement.

• Competitive salary and comprehensive benefits package.

• Collaborative and supportive work environment.

• Flexible working arrangements.