Senior Biostatistician

Employer
Rho, Inc.
Location
Research Triangle Park, NC
Posted
Oct 09, 2020
Required Education
Masters Degree/MBA
Position Type
Full time

Overview

The Senior Biostatistician will lead statistical analysis activities for assigned clinical research projects, maintaining a steady, open dialogue regarding study execution as it relates to timelines, data quality, and interpretation of the results.  Rho's team-oriented environment requires strong communication skills and the ability to collaborate closely as a member of a cross-functional study team. Rho's high quality standards require careful attention to accuracy and details.

Responsibilities

  • 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 at Rho 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

Qualifications

  • A minimum of five (5) years of 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

EOE. Veterans/Disabled