Principal Biostatistician

Rho

Posted on: September 23, 2021

Closing: October 23, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

The Principal 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 eight (8) 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

Rho is a full-service contract research organization optimally sized to deliver results from clinical research with agility and adaptability. Maximizing profitability, stability, and planned growth has helped provide us with the experience, capacities, and capabilities of a larger organization—all without losing touch with our entrepreneurial passion.

Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest. Here's how we do it:

We are dedicated to a collaborative environment with fully integrated project teams and agile corporate leadership that ensures quick responses and follow-up. It is the combination of these elements that allows us to build and sustain an engaged and happy workforce. We are proud of our outstanding retention record; our talented employees tout work-life balance and close relationships with their colleagues and clients as primary reasons for joining our organization and growing their careers with us.

These are just some of the reasons Rho has consistently been named to the Triangle Business Journal's Best Places to Work list.

By joining Rho, you will have the opportunity to work with some of the most talented minds in the industry to solve complex problems for our clients.

EOE. Veterans/Disabled

Rho

Posted on: September 23, 2021

Closing: October 23, 2021

Salary($): Undisclosed

Position Type: Full Time

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