Senior Biostatistician

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve. Currently, we at Rho are seeking a Senior Biostatistician for our Federal Research Team to work 100% remote on a permanent basis. As a Senior Biostatistician, you will have the opportunity to lead statistical analysis activities for 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 you to have open 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. Because Rho recognizes great people are our most important asset, we attract and retain the best and brightest. Why Rho? The foundation of our organization was built on Biometrics, and it continues to be a thriving focal point for our business with strong employee tenure and stability. We are large enough for strong stability, but small enough for you to have strong visibility and exposure to grow your career! Support and collaboration is everywhere – from the top down. You have plenty of artillery to be successful here It’s fun and vibrant – our culture is unbeatable Great benefits, time off and 2 promotion cycles per year! Lastly, we do great work and our studies are properly staffed, that makes for very happy people! These are just some of the reasons Rho has consistently been thought of as one of the CRO industry's best places to work for the past 38 years! Our Biometrics team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group! Function as statistical lead on complex clinical trials, from development through closeout. Design 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). Author statistical sections of study documents (e.g. protocols and SAPs). Perform 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). Utilize 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. Lead the creation of data documentation components of TMFs and regulatory submissions. Investigate novel approaches (e.g., new applications of adaptive design) for designing and analyzing clinical research projects and make strategic decisions and recommendations accordingly. Communicate analysis results and relevance to sponsor or investigators. Ensure effective, accurate and timely communication of key issues and progress to the team and Sr. Management. Exhibit the expertise to do tasks independently and to oversee, train and mentor others in task completion. Participate 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. Create integrated databases for submission to regulatory bodies. Represent sponsors at FDA meetings (type A, B, and C). Respond to information requests or other queries from regulatory bodies. Author relevant sections of briefing books and briefing packages to support FDA interactions. Advise and consult with sponsors regarding FDA data analytical and filing requirements.