Principal Biostatistician

Company: Cytel Software Corporation
Location: Gary
Posted on: November 26, 2022

Job Description:

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are hiring a remote Associate Director of - Biostatistics to lead and/or support clinical trials for a major pharma company in the therapeutic area of Oncology. This position reports to the Director, Biostatistics in the FSP Services business unit in Cytel. -Your ImpactThis position serves as the Biostatistics lead supporting multiple programs in oncology across all stages of development. - The position is responsible for providing compound level statistical expertise and leadership by assuming responsibility for innovative study designs, statistical methodology, data analysis, interpretation, and regulatory interactions and Discovery teams and teams in Shanghai, China.Major Responsibilities:

• Serves as a statistical lead for one or more oncology projects, facilitates the coordination of all statistical activities for these projects
• Participates in the design and review of clinical protocols and case report forms for projects including the preparation of statistical considerations sections, sample size calculations, interim looks, randomization, and study design recommendations. - Produces statistical section of clinical protocol
• Creates and implements statistical analysis plans and specification documents
• Carries out hands-on work associated with clinical studies and regulatory submissions -
• Communicates study results including internal communication as well as manuscripts, or oral presentations in scientific meetings
• Participates in database design, data collection guidelines, and logic checks
• Provides guidance to programmers and analysts on statistical procedures
• Identifies and works with existing external statistical experts for consultation
• Interacts and manages CROs with oversight activities, budgets, and timelines
• Keeps abreast of regulatory and methodological topics
• Develops and implements innovative statistical methodology
• Demonstrates problem solving ability and critical thinking -What we are looking for:
  • Ph.D. or M.S. in biostatistics, statistics, mathematics, or related field. - At least 5 years of experience in pharma, biotech, or a related sector
  • Proficiency in statistical programming languages/software such as SAS, R, Spotfire etc.
  • Well-versed in the clinical and regulatory requirements for global submissions
  • Advanced knowledge of clinical study designs and statistical methodologies for analysis
  • Excellent interpersonal, leadership, and communication skills
  • US-based statistician who can help communicate with Chinese counterparts
  • Thorough knowledge of operational aspects of clinical trial conduct and overall drug development
  • Strong collaborative skills and ability to work with a cross-functional teamWhat's in it for you:
    • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
    • You will be part of an exciting new chapter in Cytel's history with high growth and opportunities to learn and grow your career
    • Work with and leverage the best and brightest minds in the industry -

Keywords: Cytel Software Corporation, Gary , Principal Biostatistician, Other , Gary, Indiana