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Senior Biostatistics Director

2 months ago

Brisbane, Queensland, Australia Vera Therapeutics, Inc Full time
About the Role

We are seeking a highly skilled Senior Biostatistics Director to join our team at Vera Therapeutics, Inc. as a key member of our cross-functional product development team.

Key Responsibilities
  • Design and Execution of Clinical Trials: Contribute to the design of scientifically sound clinical trials, including the selection of study population/sample size/endpoints to address study objectives.
  • Statistical Analysis and Reporting: Author/review protocol, statistical analysis plan, clinical study reports, publications, and product level documents.
  • Collaboration and Communication: Act as the primary contact and lead project biostatistician for all biostatistics related activities outsourced to CROs and other external vendors. Work collaboratively with vendors, Clinical Research, Drug Safety, Regulatory Affairs, Clinical Operation, and Project Management teams to meet project deliverables and timelines for statistical data analysis and reporting.
  • Presentations and Publications: Present summary data and analyses results effectively. Provide statistical support and scientifically rigorous statistical expertise in addressing health authority requests, publications, presentations, and other public releases of information.
  • Study Management: Manage multiple studies to ensure consistency and adherence to standards within a therapeutic area.
  • Compliance and Quality: Responsible for complying with all company processes and SOPs.
Requirements
  • Education and Experience: PhD (5+ years) or MS (8+ years) in statistics or biostatistics or related scientific field with experience in clinical trials in the pharmaceutical or biotechnology industry.
  • Technical Skills: Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation.
  • Communication and Collaboration: Excellent communication skills with the ability to deliver difficult or complex messages and provide feedback with both tact and diplomacy. Expertise in statistical/clinical trials methodology as it relates to clinical development and ability to apply to relevant clinical development framework that will significantly advance the teams' capabilities and performance.
  • Regulatory Knowledge: Good understanding of regulatory landscape and experience with participating in regulatory interactions.
  • Strategic Thinking: Able to identify opportunities for strategic cross-functional collaborations that can carry significant impact to the business.
  • Project Management: Proven project management skills with the ability to plan, organize, and prioritize multiple work assignments.
What We Offer

Vera Therapeutics, Inc. is an equal opportunity employer. We offer a competitive total compensation package, including an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Our benefits offerings include medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.