Senior Biostatistician

Location
United States
Salary
Salary up to $120,000 depending on experience
Posted
09 Nov 2020
Closes
09 Dec 2020
Ref
ES-CRO_USA-Stats01
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

This is a fantastic opportunity to join dynamic company going through a very exciting time, as they are very busy and continue to grow. They were named Triangle Business Journal Best Places to Work for the last 8 years in a row. They have just over 300 employees and are continuing to grow. They have recently invested heavily in their Business Development team so are experiencing an increase in client wins.
 

This opportunity offers a competitive compensation package, a dynamic, friendly and supportive team, mentorship and training to further develop your skills and flexibility to work from the office or home as an option – how does that sound?

Senior Statistician role will involve:

  • Functions as statistical lead on complex clinical trials, from development through closeout
  • Designs scientifically sound clinical research projects, demonstrating understanding of all key design components (e.g., defining study objectives, study design and plan, study populations, treatment regimens as well as determining sample size requirements)
  • Authors statistical sections of study documents (e.g. protocols and SAPs)
  • Performs various types of statistical analyses of clinical research data (e.g., demographic and other baseline characteristics, measurements of treatment compliance, efficacy evaluation, safety evaluation, pharmacokinetic evaluation, and interim analysis)
  • Utilizes statistical software programs (e.g., SAS, R) to implement advanced statistical methodologies (e.g., longitudinal data analysis, survival analysis, Poisson regression, imputation methodologies and analyses with missing data) and verify underlying distributional assumptions
  • Leads the creation of data documentation components of TMFs and regulatory submissions
  • Investigates novel approaches (e.g., new applications of adaptive design) for designing and analyzing clinical research projects and makes strategic decisions and recommendations accordingly
  • Communicates analysis results and relevance to sponsor or investigators
  • Ensures effective, accurate and timely communication of key issues and progress to the team and Sr. Management
  • Exhibits the expertise to do tasks independently and to oversee, train and mentor others in task completion
  • Participates in the Biostatistics community by contributing to internal initiatives and standard operating procedures for the administration and support of clinical trials
  • Involvement with budgets, proposals, and other business development activities
  • Creates integrated databases for submission to regulatory bodies
  • Represents sponsors at FDA meetings (type A, B, and C)
  • Respond to information requests or other queries from regulatory bodies
  • Authors relevant sections of briefing books and briefing packages to support FDA interactions
  • Advise and consult with sponsors regarding FDA data analytical and filing requirements

Senior Statistician will have:

  • Experience conducting statistical analysis for clinical research projects
  • Master's or higher level degree in biostatistics, statistics, or a related field is required
  • Proficiency in SAS (in addition, proficiency in R is a plus)
  • Excellent verbal and written communication and interpersonal skills
  • Must be a self-starter, able to work independently and have the ability to coordinate multiple activities simultaneously in support of various projects

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Erick Semerene on +44 (0) 1293 584 300 and send your CV through to Erick.semerene@rbwconsulting.com or use the apply button on this page.

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