Premier Research
Biostatistics
StatisticalScientistDirector
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“Statistical Scientist Director at Premier Research. Skills: lead statistician on complex, key client studies, statistical strategy from protocol/SAP planning through reporting, communication of complex quantitative concepts to non-statistical stakeholders, project management for biostatistics stand-alone work, client advisory on regulatory guidelines and statistical principles. Serve as lead statistician on complex, key client studies. acting as point-of-contact, ensuring cohesive communication ”
Industry & Context.
Identify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies
A willingness to travel, ~20%
What They're Looking For.
Must Have
Advanced degree (MS or PhD) from accredited college or university, in statistics or closely related field, 15+ years’ experience in clinical trials design and analysis, At least 1 yr technical experience in clinical trials design and analysis implementing innovative statistical analysis, computer skills, with knowledge of advanced programming skills with standard software, including SAS, R, Excellent working knowledge of CDISC standards and application of these standards to projects, Excellent English and Host Country Communication skills (verbal, written & interpersonal)
Nice to Have
PhD preferred, Previous experience implementing innovative statistical designs, 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 Pharmaiotech sector, Demonstrated experience in interacting with regulatory agencies (e.g., FDA, EMA, EU member states), Excellent organizational and time-management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment
What You'll Do.
Serve as lead statistician on complex
acting as point-of-contact
ensuring cohesive communication with sponsors and internal teams
leading project-level statistical strategy from protocol/SAP planning through reporting
ensuring alignment of design
and data interpretation
Communicate complex quantitative concepts clearly to non-statistical stakeholders
Develops sample size estimation
adaptive or Bayesian frameworks
and innovative trial designs
Develops or provides senior oversight for statistical deliverables
Identify risks related to study design
or analysis approaches and proactively propose mitigation strategies
Acts as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget
and timeline expectations
Advise clients on regulatory guidelines
statistical principles for submissions
and global expectations
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
Acts as an independent biostatistician on DSMBs and DMCs
How You'll Work.
Team & Collaboration
ensuring cohesive communication with sponsors and internal teams; Communicate complex quantitative concepts clearly to non-statistical stakeholders—including sponsor leadership, regulatory representatives, and clinical teams; Ability to manage and de-escalate difficult situations with clients, teams, and management
Communication Scope
cohesive communication with sponsors and internal teams; Communicate complex quantitative concepts clearly to non-statistical stakeholders; Excellent English and Host Country Communication skills (verbal, written & interpersonal)
Process & Methodology
Acts as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope, and timeline expectations
Full Job 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. Join us and build your future here. **What You 'll Be Doing:** * 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 selection of protocols, statistical Analysis Plans (SAPs), randomization specifications and Statistical contributions to CSRs, publications, and regulatory documents * Identify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies. * Acts as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope, and timeline expectations. * Advise clients on regulatory guidelines, statistical pr
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