Principal Biostatistician Medical Affairs in Italy, Texas at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Biostatistician Medical Affairs in Italy.

This role sits at the intersection of clinical research, statistical science, and medical affairs, contributing directly to the development and evaluation of innovative therapies. You will be responsible for delivering high-quality statistical expertise across clinical studies, from protocol design through final reporting, ensuring accuracy, compliance, and scientific rigor. Working in a highly collaborative, global environment, you will partner with cross-functional teams including clinical operations, programming, and regulatory stakeholders. The position requires both technical depth and strategic thinking to translate complex clinical data into meaningful insights. You will play a key role in ensuring the integrity of clinical trial results and supporting regulatory and scientific decision-making. This is a remote opportunity offering exposure to large-scale, global clinical programs and advanced therapeutic areas.

• Provide statistical support across all phases of clinical projects, from protocol development through clinical study report (CSR) completion.
• Develop and review Statistical Analysis Plans (SAPs), including mock tables, figures, and listings aligned with study objectives.
• Contribute to protocol design, randomization schedules, and statistical components of clinical studies.
• Coordinate and oversee biostatistics and programming activities to ensure timely and high-quality deliverables.
• Review programming specifications, datasets, and outputs including tables, listings, and figures for accuracy and consistency.
• Validate case report forms (CRFs), database structures, and study documentation to ensure complete and analyzable data.
• Conduct quality control and verification of statistical outputs, ensuring compliance with SAPs and regulatory standards.
• Serve as a statistical representative on cross-functional project teams, contributing to planning and decision-making discussions.
• Track study timelines, manage multiple project priorities, and ensure delivery against agreed milestones.
• Support regulatory submissions, advisory boards, and data monitoring committee activities when required.
• Contribute to business development activities including proposals, budgets, and sponsor meetings.
• Mentor and guide junior biostatistics team members and support capability development.

Requirements:

• Significant experience in biostatistics within clinical trials or pharmaceutical development (minimum several years required).
• Strong background in statistical methodologies applied to clinical research and medical affairs.
• Advanced proficiency in SAS and/or other statistical programming tools.
• Experience developing SAPs, clinical trial outputs, and regulatory documentation.
• Solid understanding of clinical trial design, protocols, and regulatory guidelines (ICH standards).
• Ability to coordinate complex projects and manage multiple timelines simultaneously.
• Strong analytical skills with high attention to detail and data quality assurance.
• Experience collaborating in cross-functional, global clinical development teams.
• Excellent communication skills to explain complex statistical concepts to non-technical stakeholders.
• Ability to mentor and support junior team members in statistical practices.
• Experience in clinical trial environments is required.
• Advanced degree in Statistics, Biostatistics, Mathematics, or related field preferred.

Benefits:

• Fully remote role across multiple European locations.
• Competitive compensation aligned with experience and expertise.
• Exposure to global clinical trials and innovative therapeutic areas.
• Opportunity to work on high-impact studies influencing patient care worldwide.
• Strong professional development and career progression opportunities.
• Collaborative and international working environment.
• Access to advanced data, technologies, and clinical research resources.
• Participation in large-scale, high-visibility pharmaceutical projects.