Senior MA and HEOR Biostatistician F/M

We are seeking a Biostatistician to play a pivotal role in our Medical Affairs and Health Economics and Outcomes Research (HEOR) initiatives.

In this critical position, you will be instrumental in delivering robust statistical support for our evidence generation plans, ensuring scientific rigor and strategic alignment with medical, regulatory, and market access objectives. You will be at the forefront of contributing to value dossiers, payer submissions, and navigating the evolving landscape of HTA requirements.

Role Expectations and Main Responsibilitie

• Provide expert statistical support for Medical Affairs and HEOR evidence generation plans across assigned products, ensuring alignment with medical, regulatory, and market access objectives.

• Serve as the primary Biostatistics representative for Integrated Evidence Generation Plans (IEGP), Joint Scientific Consultations (JSC), and Joint Clinical Assessment (JCA) dossiers.

• Collaborate closely with HEOR partners, contributing clinical evidence to value dossiers and payer submissions, with a keen focus on adherence to EU HTA Regulation requirements and other payer expectations.

• Champion the use of innovative statistical methodologies by identifying, adapting, developing, or applying optimal statistical research techniques to address evidence gaps.

• Continuously monitor evolving HTA requirements, regulatory guidance, and industry standards, recommending necessary adjustments to internal practices to maintain compliance and competitiveness.

• Offer comprehensive statistical support for HTA-related analyses, post-marketing studies, retrospective and observational studies, registry studies, indirect treatment comparisons, and patient-reported outcome research.

• Author and meticulously review Statistical Analysis Plans (SAPs), including table, listing, and figure (TLF) shells. Oversee the execution of statistical analyses, upholding methodological rigor, quality control, and appropriate interpretation of results.

• Review protocols, study reports, briefing materials, and publications to guarantee scientific robustness and consistency.

• Represent Biostatistics on cross-functional medical and evidence generation teams, influencing strategic decision-making through clear articulation of statistical perspectives.

• Support regulatory and payer interactions involving real-world evidence or outcomes-based data packages, including prompt responses to statistical inquiries.

• Provide robust oversight of Contract Research Organizations (CROs) and external statistical vendors, ensuring strict adherence to methodological standards and regulatory expectations.

• Coordinate or contribute significantly to departmental process improvement initiatives and the development/revision of Standard Operating Procedures (SOPs).

Required Skills and Experience

Educational & Professional Background:

• Master or Doctoral degree or equivalents in Biostatistics, Statistics or closely related fileds.
• At least 8 years’ experience as statistician supporting clinical development, Medical Affairs, and HEOR evidence generation

Hard Skills :

• Experience in real-world evidence, post-approval studies, indirect treatment comparisons, and HTA-related submissions.
• Familiarity with regulatory guidance (ICH, FDA, EMA) and HTA frameworks (e.g., EU-HTA, ISPOR).
• Proficiency in SAS and R.

• Experience contributing statistical inputs to regulatory or payer interactions strongly preferred.
• Demonstrated ability to independently determine appropriate study designs and analytical strategies.
• Oncology experience is preferred.
• English fluency is required

Leadership Skills:

• Proven ability to manage CRO partnerships and ensure adherence to best practices.

• Demonstrated leadership and mentoring capability

Soft Skills:

• Excellent communication skills, including the ability to present complex statistical concepts clearly to non-statistical audiences.

• Project management skills with the ability to manage multiple competing priorities
• Excellent team player, collaborative and maintains a positive, results-orientated work environment