Statistical Scientist Director Organization

• 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.
• Develops sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
• Develops or provides 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 and influence decision-making through evidence-based recommendations.
• Provides 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.

• Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field. Equivalent combination of education, training and experience will be considered.
• 15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment
• At least 1 yr 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 conduct of clinical trials in the respective area of focus as demonstrated by past positions related to the therapeutic area in the CRO and Pharma/Biotech sector
• Strong computer skills, with knowledge of advanced programming skills with standard software, including SAS, R, Analysis Skills, Bayesian Networks, Biostatistics, Biotech and Pharmaceutical, Business Development, Clinical Trial, Computer Programming, Computer Skills, Contract Research Organization (CRO), Data Analysis, Leadership, Medical Products, Predictive Modeling, Protocol Analysis, R Programming Language, Regulations, Request for Proposals (RFP), SAP, Statements on Auditing Standards (SAS), Statistical Analysis System (SAS), Statistics, Unix Shell Programming

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized starting base pay for this role is $186,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Title: Statistical Scientist Director Organization: Premier Research International LLC Description:

Premier Research is looking for a Statistical Scientist Director to join our Biostatistics team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
• Your ideas influence the way we work, and your voice matters here.
• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.