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.
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
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
About Rho, Inc.
Changing what it means to work with a CRO.
At Rho, we believe expertise is everything. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities.
Our experts take clients beyond procedural operations and into truly proactive problem-solving. Through a collaborative approach and individualized attention, our focus is advancing your program so that together, we can help heal the world.
That is what drives us.