Senior Principal Clinical Statistician in Santa Rosa at Apple & Associates

Date Posted: 2/13/2018

Job Snapshot

Job Description

Senior Principal Statistician - Clinical Studies - Vascular
Work Remotely 

Our client, the world leader in medical device product development and manufacturing, has a new opening for a high-level clinically experienced biostatistician.
As the Senior Principal Statistician, you will provide statistical expertise and leadership for clinical studies and clinical study teams and other statistical staff in the Vascular Study organization to satisfy applicable regulatory standards and requirements.  This includes protocol development, study design, and data analysis and presentation for regulatory submissions and marketing and physician requests.
  
Senior Principal Statistician Responsibilities:
  • Provide statistical leadership and guidance in the completion of major clinical programs.
  • Consult with staff on statistical and analysis issues.
  • Provide leadership in the design of complex clinical studies.  Participate in the development of study protocols, including refinement of the study objectives and endpoints.  Responsible for study design, including statistical hypotheses and sample size estimation; and statistical analysis plan.  Prepares statistical sections of protocols.  Writes statistical analysis plans for studies.  
  • Provide statistical expertise and leadership for regulatory submissions; including statistical methods, table and graph shells and statistical programming specifications, analyses and data presentation, interpretation of results, and report writing; and to study teams in responses to regulatory agencies, negotiations with regulatory agencies, and in meetings with regulatory agencies.
  • Provide statistical expertise and leadership for marketing and physician requests; including statistical methods, table and graph shells and statistical programming specifications, analyses and data presentation, and interpretation of results for abstracts, presentations, and manuscripts.
  • Provide leadership in the development and implementation of statistical process improvements. 
  • Evaluate new statistical methodologies and provide leadership in their development and implementation for the analyses of clinical data.
  • Participate in the development and improvement of the database systems, including specifications for the database design to assure the availability and quality of the clinical study data. 
  • Identify potential threats to study credibility and validity; work with study teams to prevent and manage potential problems.
  • Assist clinical staff with other duties as requested.
    
Senior Principal Statistician Requirements:
  • Minimum of a Masters degree in statistics, biostatistics, biometry, or epidemiology    
  • 12 years of experience with Masters (9 years with PhD) in the design and analysis of clinical studies, class III medical device or complex clinical studies, including strategic decision on what makes the study statistically significant, passion for studies to be accurate and knowledge of how the product (medical device) works.
  • Advanced statistical skills including: Bayesian methods, group sequential methods, survival analysis, regression modeling, longitudinal analysis (including mixed models), data mining, missing data strategies, and multiple testing strategies
  • Clinical Study Design Experience from statistical significance perspective
  • Leadership and Approval of FDA or PMDA regulatory requirements

Preferred Qualifications:

•    Advanced knowledge of clinical trial study design and methodology
•    Knowledge of and/or experience with statistical programming packages, including SAS.


CHECK OUT OUR SIMILAR JOBS

  1. Statistician Jobs
  2. Biostatistician Jobs