Statistical Scientist Director

Premier Research Group; Argentina; Remote; ARS 1,800,000 - 3,000,000; Full time

Job summary

Premier Research Group is seeking a Statistical Scientist Director to lead our Biostatistics team in a remote Argentina role. You will pilot statistical strategy from protocol design through reporting, interfacing with sponsors and internal teams.

Ideal candidates hold an MS or PhD in statistics or related field, with 15+ years in clinical trials and expertise in SAS, R, CDISC, and regulatory submissions; travel up to 20% may be required.

Qualifications

• Advanced degree (MS or PhD) in statistics or closely related field.
• 15+ years of experience in clinical trials design and analysis, preferably in CROs.
• At least 1 year in technical design/analysis implementing innovative statistical methods.
• Strong knowledge of regulatory, scientific, technical and clinical conduct in trials.
• Excellent English and host country communication skills, and ability to travel ~20%.

Responsibilities

• Serve as lead statistician on complex client studies, guiding project-level strategy from protocol planning to reporting.
• Communicate complex concepts clearly to sponsors, regulatory bodies, and clinical teams.
• Develop sample size estimation, adaptive or Bayesian methods, and innovative trial designs.
• Provide oversight for SAPs, CSR contributions, and regulatory documents.
• Identify risks and propose mitigation strategies, manage timelines and budgets.

Skills

SAS

R

Statistics

Clinical trials design

Regulatory knowledge

CDISC standards

Communication

Education

MS or PhD in Statistics or related field

Tools

SAS

R

Job description

## Statistical Scientist DirectorApply: Remote: Argentina: Full time: Posted 9 Days Ago: R7041Premier 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 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%