• Direct Hire
  • San Clemente, California

SimulStat

Senior/Principal Biostatistician, based in San Clemente, eventually, Aliso Viejo, CA will be responsible for statistical analysis activities for assigned clinical studies. These include creating, reviewing, and maintaining statistical analysis plans, performing statistical analyses, providing data interpretation and participating in protocol development and the preparation of clinical study reports.

Responsibilities:

  • Provide statistical input including development of study design, formulating study endpoints, implementing appropriate statistical analysis methods
  • Perform sample size and power calculations
  • Author statistical section of study protocols and study reports
  • Prepare and maintain statistical analysis plans (SAP) for individual studies, ISS and ISE ensuring that appropriate statistical methods are utilized
  • Create shells (mock-ups) for tables, listings, and figures
  • Represent Biostatistics in study and project team meetings
  • Represent Biostatistics in meetings with regulatory agencies
  • Collaborate with Statistical Programming on the implementation of the SAP
  • Conduct statistical analyses and perform SAS programming, as needed
  • Provide statistical analyses support to publications (e.g. abstracts, presentations and posters, manuscripts)
  • Review registration documents and publications to ensure data interpretation is statistically sound and accurate and consistent with data presentation
  • Develop or assist in the development of departmental processes and procedures.
  • Maintain study documentation of statistical analyses and supportive documents
  • Ensure adherence to industry standards and regulatory requirements, including but not exclusive to Good Clinical Practices (GCP) and ICH guideline on Statistical Principles for Clinical Trials
  • Ensure that statistical/programming policies, guidelines, and procedures are followed

 

Qualifications:

  • PhD or MS in Statistics, Biostatistics or other related discipline is required
  • Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry as a Biostatistician is required (>= 4 years with PhD degree; >=6 years with MS degree)
  • Proficient with SAS programming and other statistical software (e.g., R, PASS)
  • Experience with regulatory submissions
  • Knowledge of the drug development process
  • Basic knowledge of global regulatory requirements and standards for statistical applications in the conduct of Clinical Research
  • Knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs
  • Maintains expertise in state-of-the-art statistical methodology and regulatory requirements
  • Ability to learn and utilize new methodologies
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