Bio Statistician

"The successful candidate will be responsible for statistical aspects of clinical, preclinical (analytical) research and development and life cycle management projects of veterinary vaccines. Project responsibilities include study design, case report form development, analysis planning and scheduling, analysis and interpretation of data, and reporting of results. May be required to coordinate analysis efforts across multiple research projects and campuses conducted for Global Biological R&D."

Responsibilities:

• Responsible for statistical aspects of projects, including experimental design, analysis, and presentation of data.
  • Maintains consistent approaches within and across biological research and development projects.
  • Serves as a statistical consultant and advisor in study design, sample size estimation, randomization, statistical analyses, and interpretation of data.
  • Ensures that all project-related work is carried out in accordance with CEVA SOPs.
  • Develops study specific procedures (SSPs) for assigned projects as required and ensures that project team members adhere to the SSPs.
  • Responsible for statistical aspects of case report form (CRF) design and related study plan appendices.
  • May serve as a Project Manager for projects that are primarily data management, biostatistics, or statistical programming in scope.
  • Develops statistical analysis plans, including the definition of derived data sets and the design of templates for statistical tables, figures, and/or data listings for clinical summary reports.
  • Understands and uses relevant computer languages and software packages. Writes programs to select, retrieve, manipulate, edit, and analyze data.
  • Responsible for the accuracy and completeness of analyses conducted for assigned projects.
  • Conducts statistical analyses and interprets results of these analyses.
  • Prepares statistical summary reports.
  • Writes the statistical methods sections of integrated study plans and reports.
  • Reviews and approves draft integrated study plans and reports.
  • Documents and archives analysis and programming work to ensure a complete audit trail.
  • Participates in the setting of project document standards.
  • Manages statistical projects for high quality, within budget, and on-time completion.
  • Establishes and maintains effective working relationships with sponsors, regulatory Affairs and CEVA project team members, including data management personnel, statistical programmers, and clinical research personnel.
  • Participates in presentations at CEVA meetings or with regulatory authorities if needed.
  • Assists in the preparation and review of bio statistical input to CEVA research proposals.
  • Researches and applies new statistical procedures as needed.
  • Provides appropriate statistical input for regulatory submissions and responds to statistical questions raised by regulatory agencies.
  • Assists in training of CEVA staff in Biostatistics.
  • Assists in interviewing and training of new staff.

Requirements:

• Bachelor Degree. Post Graduate education in relevant discipline is strongly desired.
  • Minimum of 4 years clinical research/pharmaceutical or related experience.
  • In-depth knowledge of study designs, and statistical analysis conventions in one or more therapeutic areas.
  • Significant proven experience in a similar role.
  • Excellent verbal and written communication skills are required.
  • Knowledge in applied parametric and nonparametric statistics and strong SAS programming skills are a must.
  • Knowledge in Statgraphics Plus / Centurion is desired.
  • Must be able to translate sponsors’ needs into statistical practice and educate study directors / monitors and test facility managers in the use of statistics.
  • Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, ) Organizational skills, flexibility, and ability to multitask
  • Verbal and written communication skills
  • Experience working on cross-functional teams
  • Ability to travel 5%