Senior Biostatistician

Role Overview

• 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.

Requirements

• Master's or higher level degree in biostatistics, statistics, or a related field along with 4-5 years of experience conducting statistical analysis for clinical research projects; proficiency in SAS.
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

Benefits

• Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k).
• All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
• Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.