Senior Biostatistician I
Anywhere, United States
Job Description
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 3 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!
Responsibilities
- 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.
Qualifications
- 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.
A few more things to know about 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.
Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.
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.
As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $115,000 to $135,000 per year
EOE. Veterans/Disabled
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Career Focus: Analyst, Biostatistics/Bioinformatics, Quality
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