Scientist, Research Informatics Research Informatics Associate/Senior Associate
DIRECTOR/SR DIRECTOR, BIOSTATISTICS

BRIS 1.009

Job Objective:

Experienced, creative, biostatistician to join our growing development team and lead the biostats support for Early Development candidates in Phase 1 and Phase 2 studies. In addition, to provide guidance and assistance to research and discovery colleagues on experimental design, data analyses and visualization.

Details:

  • Assist research and development teams by providing analytical strategies with a focus on biostatistics and/or biology in major therapeutic areas and diseases;
  • Develop statistical analysis plans to achieve study objectives for clinical trials;
  • Identify, evaluate, refine and recommend statistical methods for use in analysis as appropriate ;
  • Work effectively with biostatistics and data management CROs;
  • Perform statistical analysis and programming (R, SAS, and other appropriate languages) in-house ,as needed;
  • Provide quality control and statistical analysis of a wide spectrum of datasets (clinical safety and efficacy data, biomarker data, translational research data including biomarker data;
  • Validate statistical results with team members to ensure high quality deliverables;
  • Identify, interpret and present meaningful findings to key individuals (i.e. answer the “so what” questions) ;
  • Have the ability to communicate complex analyses to varied audiences;
  • Provide technical writing for analysis plans, protocols and regulatory documents as needed, and summarize results (i.e. tables, figures and listings) for inclusion in presentations or reports;
  • Provide guidance to research and discovery colleagues on study design, data analyses, statistical methodologies with a focus on biostatistics, biology and programming
  • Initiate building of in-house stats controlled environment (as needed) and data analysis archives.

REQUIREMENTS:

  • PhD. with 5+ years of experience working with clinical data (Preferred degree in Biostatistics or other Biology focused degree with a focus on statistical methods) or M.S. degree with 5-8 years’ relevant work experience in early stage drug development.
  • Proficiency in R programming for analyses and data visualization is required; proficiency in both R and SAS is preferred; experience in R package development and/or Shiny app development is a plus.
  • Training in the theory and application of biostatistics is required; knowledge of high dimensional data analysis is preferred.
  • Experience with Bayesian approaches to enable nimble adaptive designs.
  • Experience with interpretation of data and/or analytical findings in the context of providing meaningful value to project teams and upper management.
  • Health authority interaction experience and working knowledge of FDA and EMA statistical requirements
  • Interest in leveraging public data and/or databases to aid in the interpretation of data and/or analytical findings (experience and/or interest in model-based meta-analysis)
  • Proven ability to work independently and in a team environment
  • Motivation in continued learning of biological knowledge, statistical methodologies, and programming skills
  • Excellent analytical and problem-solving skills
  • Excellent written and verbal communication skills

Please send resume and cover letter