Director, Biostatistics & Clinical Innovation

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 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.