Statistical Scientist Director

73 Premier Research Argentina; Argentina; On-site; ARS 181,747,000 - 272,620,000; Full time

Job summary

Premier Research is seeking a Statistical Scientist Director to join our Biostatistics team. You will lead as the primary statistician on complex client studies, communicating with sponsors and internal teams and shaping statistical strategy from protocol through reporting.

You will advise on regulatory guidelines and ensure adherence to CDISC, with extensive experience in trials design, Bayesian/innovative designs, and collaboration with CRO partners. Travel ~20% may be required.

Qualifications

• 15+ years of experience in clinical trials design and analysis, preferably in CROs.
• At least 1 year of technical experience in clinical trials design and analysis implementing innovative statistical methods.
• Previous experience implementing innovative statistical designs.
• Strong knowledge of regulatory, scientific, technical and clinical aspects of trials.
• Excellent English and host country communication skills.

Responsibilities

• Serve as lead statistician on complex, key client studies, acting as point-of-contact and leading project-level statistical strategy.
• Communicate complex quantitative concepts clearly to non-statistical stakeholders.
• Develop sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
• Oversee statistical deliverables such as SAPs, CSRs, and regulatory documents; identify risks and mitigation strategies.
• Act as project manager for biostatistics work, managing budget, scope, and timelines.
• Advise clients on regulatory guidelines and global expectations (FDA, EMA, etc.).
• Support business development through bid defenses and sponsor engagements.
• Act as independent biostatistician on DSMBs/DMCs.

Skills

Lead statistician

15+ years clinical trials

SAS

R

CDISC standards

Regulatory knowledge

FDA/EMA experience

English proficiency

Travel availability

Education

MS or PhD in Statistics

Tools

SAS

R

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 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%

Premier Research is more than a company – it’s a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems. Our Values – We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care – mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning.

Introduce yourself to our Talent Team and we will reach out if there is a role that aligns with your experience and interests.

Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose.

Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high – we will not stop until we reach our goals. And we care about each other, about our customer and partners, and, most importantly, about all the patients that we touch with our work.