ppPremier 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. /p pJoin us and build your future here. /p ul liWe 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. /li liYour ideas influence the way we work, and your voice matters here. /li liAs an essential part of our team, you help us deliver the medical innovation that patients are desperate for. /li /ul h3What You'll Be Doing /h3 ul liServe 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. /li liCommunicate complex quantitative concepts clearly to non-statistical stakeholders—including sponsor leadership, regulatory representatives, and clinical teams. /li liProvide statistical input to Clinical Trial Reports and Clinical Trial Protocols. /li liDevelop sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs. /li liDevelops or provides senior oversight for statistical deliverables, including: ul listatistical selection of protocols /li liStatistical Analysis Plans (SAPs) /li liRandomization specifications /li liStatistical contributions to CSRs, publications,



and regulatory documents /li /ul /li liCollaborate closely with statistical programmers to ensure proper implementation of methods and accurate interpretation of outputs. /li liIndependently develop SAS/R programs as needed. /li liIdentify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies. /li liActs as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope, and timeline expectations. /li liOversee cross-project statistical consistency, supporting portfolio-level scientific strategy when applicable. /li liAdvise clients on regulatory guidelines, statistical principles for submissions, and general expectations (FDA, EMA, PMDA, etc.). /li liSupport 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. /li liProvides 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. /li liKeeps up with new and upcoming statistical techniques as well as regulatory authority developments, mentors and trains department members, and support the development and maintenance of departmental training, SOPs and guidelines.



/li liActs as an independent biostatistician on DSMBs and DMCs. /li liPerform other work-related duties as assigned /li /ul h3What We Are Searching For /h3 ul liAdvanced 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. /li li15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment. /li liAt least 1 yr technical experience in clinical trials design and analysis implementing innovative statistical analysis. /li liPrevious experience implementing innovative statistical designs. /li liStrong 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. /li liStrong computer skills, with knowledge of advanced programming skills with standard software, including SAS, R. /li liExcellent working knowledge of CDISC standards and application of these standards to projects. /li liAbility to communicate basic statistical concepts to other scientists and nonscientists. /li liAbility to manage and de-escalate difficult situations with clients, teams, and management. /li liDemonstrated experience in interacting with regulatory agencies (e.g., FDA, EMA, EU member states). /li liDemonstrated critical thinking with a history of bringing forward strategic initiatives. /li liExcellent English and Host Country Communication skills (verbal, written interpersonal). /li liExcellent organizational and time-management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment. /li liA willingness to travel, ~20%. /li /ul /p #J-18808-Ljbffr

📌 Statistical Scientist Director (España)
🏢 Premier Research
📍 España