Principal Statistician

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Lead the strategic planning, design, analysis, and reporting efforts for one or more clinical research projects or sponsor programs.

• Develop and assess Statistical Analysis Plans, study protocols, randomization techniques, and other essential statistical deliverables.

• Offer expert statistical advice to sponsors, project teams, and external stakeholders throughout the entire clinical trial lifecycle.

• Supervise the creation, validation, and evaluation of SAS programs, derived datasets, SDTM/ADaM datasets, and statistical outputs.

• Produce high-quality tables, figures, listings, reports, and ad hoc analyses to support study objectives and facilitate decision-making.

• Collaborate with cross-functional teams, sponsors, vendors, and regulatory stakeholders to fulfill statistical and reporting needs.

• Mentor and provide guidance to biostatisticians on study design, analytical methods, and statistical techniques.

• Contribute to initiatives aimed at improving processes, enhancing quality, developing policies, and preparing for inspections to boost efficiency and data integrity.

• Represent the biostatistics function in sponsor meetings, external forums, and scientific discussions, staying informed about evolving statistical and regulatory trends.

⛳️ Requirements

• BSc with a minimum of 8 years' relevant experience, MSc with at least 6 years' relevant experience, or PhD with a minimum of 4 years' relevant experience in biostatistics or a related field.

• Proven experience as a lead or project biostatistician, offering statistical leadership throughout clinical research studies.

• Extensive experience applying statistical methods across various phases of clinical development and in a range of therapeutic areas.

• Strong understanding of clinical trial design, statistical analysis, regulatory standards, and interactions within regulated research environments.

• Advanced SAS programming skills, including experience with SDTM, ADaM, derived datasets, and statistical reporting outputs.

• Exceptional project planning, prioritization, and time management abilities, with the capacity to manage multiple studies concurrently.

• Excellent communication, consulting, influencing, and relationship-building skills, with experience working collaboratively across multidisciplinary teams and with external stakeholders.

• Proficient in English, possessing strong written and verbal communication capabilities.

🏝️ Benefits

• Collaborative and inclusive work environment.

• Opportunities for growth and career development.

• Chance to learn and advance professionally.

• Mentorship and professional development opportunities.

• Opportunity to contribute to statistical methodologies and best practices.