Principal Biostatistician – Medical Affairs

This is a fully remote position, open to applicants in France, +7 more countries.

📋 Description

• Deliver strategic statistical expertise and oversight for clinical research programs, especially Phase IIIb/IV clinical trials, observational studies, and patient registries.

• Act as a key statistical representative within cross-functional teams, providing scientific leadership across various studies and projects.

• Offer statistical oversight and expertise for clinical trials, observational studies, patient registries, and additional clinical research initiatives.

• Lead or assist in the design of clinical studies, statistical analysis planning, and interpretation of results.

• Develop and review Statistical Analysis Plans (SAPs) and Data Presentation Plans (DPSs).

• Support post-hoc analyses, investigator-initiated studies, and other research activities.

• Ensure scientific rigor, statistical integrity, and quality of clinical research deliverables.

• Collaborate with Medical Affairs, HEOR, Epidemiology, Market Access, and other functions on strategies for evidence generation.

• Provide statistical input related to product development and regulatory submission activities.

• Assist in publication planning and scientific communications.

• Serve as the primary statistical contact for external investigators, research partners, and vendors.

• Collaborate on scientific manuscripts, publications, abstracts, and conference presentations.

• Engage with external Key Opinion Leaders (KOLs) regarding scientific discussions and research initiatives.

• Communicate complex statistical findings to both technical and non-technical audiences.

• Conduct thorough statistical analyses for critical business research questions and evidence generation activities.

• Explore and implement innovative statistical methodologies.

• Identify opportunities to enhance statistical approaches, analytical efficiency, and the scientific value of research outputs.

• Contribute to the ongoing improvement of statistical practices and processes.

⛳️ Requirements

• PhD or MSc in Statistics, Biostatistics, or a related field.

• At least 6 years of relevant experience for PhD holders or 8 years for MSc holders.

• Preferred prior experience supporting statistical activities within Medical Affairs in the pharmaceutical or biotechnology sector.

• Proven experience working independently as a statistical contributor and providing scientific leadership across multiple projects.

• Preferred experience within a cross-functional, matrix-based organization.

• Extensive working knowledge of SAS and R.

• Intermediate to advanced expertise in applied biostatistical methodologies, particularly in pharmaceutical and clinical research contexts.

• Strong understanding of clinical trial design, statistical analysis, data interpretation, and evidence generation.

• Familiarity with Good Clinical Practice (GCP) and regulatory requirements governing clinical drug development and trials.

• Ability to apply suitable statistical methodologies to complex scientific and clinical research inquiries.

• Excellent written and verbal communication skills.

• Experience presenting statistical findings to both technical and non-technical audiences, including at public or scientific meetings.

• Strong scientific writing skills and a background in contributing to peer-reviewed publications and journal articles is preferred.

• Ability to cultivate effective relationships and collaborate with internal stakeholders, external investigators, and scientific experts.

• Strong influencing, negotiation, and stakeholder management skills.

• Capacity to manage multiple priorities and projects efficiently.

• Highly organized, proactive, and able to work independently with minimal supervision.

• Strong analytical thinking, problem-solving abilities, and attention to detail.

• Excellent teamwork and collaboration skills.

• Commitment to scientific excellence, innovation, and continuous improvement.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.