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 principles for submissions, and global expectations (FDA, EMA, PMDA, etc.).
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
What We Are Searching For
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
Excellent working knowledge of CDISC standards and application of these standards to projects.
Ability to manage and de-escalate difficult situations with clients, teams, and management
Demonstrated experience in interacting with regulatory agencies (e.g., FDA, EMA, EU member states)
Excellent English and Host Country Communication skills (verbal, written & interpersonal).
Excellent organizational and time-management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment
A willingness to travel, ~20%
Skills Required
- Advanced degree (MS or PhD) in statistics or related field
- 15+ years' experience in clinical trials design and analysis
- At least 1 year technical experience in clinical trials design and analysis
- Strong knowledge of regulatory and clinical trial expertise
- Advanced programming skills with SAS and R
- Excellent organizational and time-management skills
What We Do
We’re out to change the course of medical science. Are you ready to rise to the challenge? Premier Research is not about being everything to everyone. Instead, our deep, focused expertise targets the therapeutic areas and indications where today’s biotech and specialty pharma pioneers are doing the most amazing work. We’re 1,500 employees strong and operate in more than 20 countries, delivering unmatched expertise, operational skills, and dedication to meeting customers’ most challenging needs. Join us and meet some of the brightest minds in clinical development today — people who apply their best thinking to every project, recognizing that what they do significantly affects the lives and well-being of customers, patients, physicians, and colleagues. You’ll enjoy great benefits and very flexible working conditions in a company that values your contributions, rewards your achievements, and is committed to helping you reach your full potential. Are you ready to make a real difference and help us transform this exciting industry? Follow our company page for more information about us and the work we do, and check out our current openings for your next career move!
