Statistical Scientist Director

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7a68jl

ppPremier Research is looking for a Statistical Scientist Director to join our Biostatistics team. /ppYou 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. /pulliWe 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. /liliYour ideas influence the way we work, and your voice matters here. /liliAs an essential part of our team, you help us deliver the medical innovation that patients are desperate for. /li /ulpJoin us and build your future here. /ph3What You’ll Be Doing /h3ulliServe 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. /liliCommunicate complex quantitative concepts clearly to non-statistical stakeholders—including sponsor leadership, regulatory representatives, and clinical teams. /liliDevelops sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs. /liliDevelops 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 /liliIdentify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies. /liliActs as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope,



and timeline expectations. /liliAdvise clients on regulatory guidelines, statistical principles for submissions, and global expectations (FDA, EMA, PMDA, etc.). /liliSupport 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. /liliActs as an independent biostatistician on DSMBs and DMCs /li /ulh3What We Are Searching For /h3ulliAdvanced 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. /lili15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment /liliAt least 1 yr technical experience in clinical trials design and analysis implementing innovative statistical analysis. /liliPrevious experience implementing innovative statistical designs /liliStrong 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 /liliStrong computer skills, with knowledge of advanced programming skills with standard software, including SAS, R /liliExcellent working knowledge of CDISC standards and application of these standards to projects. /liliAbility to manage and de-escalate difficult situations with clients, teams, and management /liliDemonstrated experience in interacting with regulatory agencies (e.g., FDA, EMA, EU member states) /liliExcellent English and Host Country Communication skills (verbal, written interpersonal). /liliExcellent organizational and time-management skills, able to prioritize work to handle multiple tasks and meet deadlines in a dynamic environment /liliA willingness to travel, ~20% /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7a68jl