Statistical Scientist Director

11 Premier Research International LLC; North Carolina; On-site; USD 167,400 - 204,600; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

11 Premier Research International LLC is seeking a Lead Biostatistician based in North Carolina. This role involves serving as the lead on complex client studies, ensuring effective communication with stakeholders, and providing senior oversight for statistical deliverables.

The ideal candidate will have an advanced degree and over 15 years of experience in clinical trials design and analysis, strong proficiency in statistical programming with SAS and R, and the ability to communicate complex concepts to non-specialists. A comprehensive benefits package is included.

Qualifications

• 15+ years of experience in clinical trials design and analysis, preferably in a CRO environment.
• At least 1 year of technical experience implementing innovative statistical analysis.
• Strong computer skills with advanced programming in SAS and R.

Responsibilities

• Lead statistician on client studies, ensuring cohesive communication.
• Communicate complex quantitative concepts to non-statistical stakeholders.
• Develop innovative trial designs and provide oversight for statistical deliverables.

Skills

Statistical analysis

Regulatory knowledge

Clinical trials expertise

SAS programming

R programming

Education

Advanced degree (MS or PhD) in statistics or related field

Job description

Responsibilities

• Serve as lead statistician on complex, key client studies, acting as point-of-contact, ensuring cohesive communication with sponsors and internal teams, and leading project-level statistical strategy from protocol/SAP planning through reporting, ensuring alignment of design, analyses, and data interpretation.
• Communicate complex quantitative concepts clearly to non-statistical stakeholders—including sponsor leadership, regulatory representatives, and clinical teams.
• Develop sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
• Provide senior oversight for statistical deliverables, including statistical sections of protocols, Statistical Analysis Plans (SAPs), randomization specifications, shell outputs, tables, listings, and figures.
• Support business development through participation in bid defenses, capabilities presentations, RFP strategy, and build trusted scientific relationships with sponsors to influence decision-making through evidence-based recommendations.
• Provide internal consultancy to team members (internal/external to Biostatistics) on statistical issues, acting as an SME for multiple statistical topics and championing innovative methodologies such as adaptive designs, Bayesian methods, and predictive modeling.

Qualifications

• Advanced degree (MS or PhD) in statistics or a closely related field, or an equivalent combination of education, training, and experience.
• 15+ years of experience in clinical trials design and analysis, preferably in a CRO environment.
• At least 1 year of technical experience in clinical trials design and analysis implementing innovative statistical analysis.
• Previous experience implementing innovative statistical designs.
• Strong knowledge of regulatory, scientific, technical, and clinical expertise in the conduct of clinical trials in the therapeutic area in the CRO and Pharma/Biotech sector.
• Strong computer skills, with knowledge of advanced programming skills with standard software, including SAS and R.

Compensation and Benefits

• Annualized starting base pay: $186,000.00 USD. Salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.
• Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

EEO Statement

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.