Biostatistics Director Remote Jobs in Raleigh, NC

RTI Health Solutions (RTI-HS), a wholly owned subsidiary of RTI International, is an independent and internationally recognized research organization. With offices in the US, UK, Spain, France, and Sweden, we provide healthcare consulting and research expertise to optimize decision making for pharmaceutical, biotechnology, and medical device products across the development and marketing lifecycle. Clients rely on our expertise, quality standards, and integrity to guide their product development and regulatory and market access strategies. Our various practice areas include Value, Access, and HEOR; Patient-Centered and Outcomes Research; Epidemiology and Biostatistics; Medical Communications; Global Business Operations; and Strategic Consulting and Growth.

We are currently seeking an Associate Director to join our growing Biostatistics team. In this role, you will perform statistical research tasks of moderate to high technical complexity, with a strong focus on the planning and analysis of patient-reported outcomes and other clinical outcome assessments in clinical trial and real-world data. You will lead the development of statistical analysis plans, oversee and/or conduct analyses, and lead proposal development under limited supervision while collaborating closely with multidisciplinary project teams.

This role may be hybrid or fully remote, with a preference for candidates located in North Carolina.

As part of the application process, candidates are required to submit a short cover letter outlining their relevant experience and alignment with the role.

As part of the application process, candidates are required to submit a short cover letter outlining their relevant experience and alignment with the role.

• Plan, conduct, and document statistical analyses for clinical trials and observational studies, with an emphasis on analysis of patient-reported outcomes.
• Develop simple to moderately complex statistical analysis plans and contribute to more complex SAPs under supervision.
• Write statistical sections of study reports, protocols, and proposals.
• Ensure the quality, accuracy, and timeliness of statistical analyses and programming outputs.
• Provide statistical and methodological solutions to internal, cross-functional project teams.
• Mentor and oversee less experienced staff on selected project tasks.
• Learn and apply new statistical methods in response to evolving project and research needs.
• Contribute to the scientific reputation and professional development of the biostatistics group and prepare presentations for external audiences.

To be successful in this role, you will have strong analytical, organizational, and problem-solving skills; a high level of written and verbal communication skills, and the ability to manage multiple tasks, meet timelines, and work effectively in collaborative team environments.

• Master's degree and at least 6 years of experience, PhD and at least 1 years of experience, or equivalent combination of education and experience.
• Demonstrated programming skills in SAS, including experience developing reproducible analysis pipelines.
• Demonstrated experience analyzing patient-reported outcome data in clinical trials including application to the estimand framework .
• Background in biostatistics or related quantitative disciplines.
• Knowledge of Good Clinical Practice (GCP), quality assurance principles, and regulatory environments.

Preferred

• Experience in the pharmaceutical industry.
• Experience interacting with regulatory agencies, including FDA, EMA, or other global health authorities.

• Familiarity with R, machine learning, and natural language processing.
• Experience with causal inference methods (e.g., propensity score methods, weighting, marginal structural models) and external control arms studies.

#LI-BM1

For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.

RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.

At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.

• Master's degree and at least 6 years of experience, PhD and at least 1 years of experience, or equivalent combination of education and experience.
• Demonstrated programming skills in SAS, including experience developing reproducible analysis pipelines.
• Demonstrated experience analyzing patient-reported outcome data in clinical trials including application to the estimand framework .
• Background in biostatistics or related quantitative disciplines.
• Knowledge of Good Clinical Practice (GCP), quality assurance principles, and regulatory environments.

Preferred

• Experience in the pharmaceutical industry.
• Experience interacting with regulatory agencies, including FDA, EMA, or other global health authorities.

• Familiarity with R, machine learning, and natural language processing.
• Experience with causal inference methods (e.g., propensity score methods, weighting, marginal structural models) and external control arms studies.

#LI-BM1