Position Summary
An established healthcare organization is seeking a seasoned statistical leader to support post-approval research and evidence generation within its Medical Affairs function. This individual will play a critical role in ensuring the scientific rigor and quality of statistical input across observational studies, health technology submissions, and scientific publications. The role sits within a collaborative and evolving biometrics team focused on real-world data and post-marketing insights.

Key Responsibilities

• Lead statistical strategy and execution for one or more therapeutic programs within Medical Affairs.

• Serve as the primary statistical representative on cross-functional teams, ensuring robust analytical plans for post-approval studies and external dissemination of data.

• Manage timelines, deliverables, and quality across internal and outsourced statistical analyses.

• Apply and oversee advanced statistical methodologies for real-world and observational research, ensuring scientific validity and regulatory readiness.

• Foster collaboration across data science, clinical, and medical functions to embed statistical thinking into key initiatives.

• Support internal innovation and development through participation in broader departmental initiatives.

• Mentor junior team members and provide subject matter expertise as needed.

Qualifications

• Doctorate in Statistics, Biostatistics, or a related field, with 8+ years of relevant industry experience.

• Comprehensive understanding of the drug development lifecycle, especially in the post-approval phase.

• Proficient in designing and analyzing clinical research using tools such as SAS and R, with working knowledge of industry data standards (e.g., SDTM, ADaM).

• Demonstrated experience with observational studies, real-world data analyses, and HTA dossier preparation.

• Strong project leadership, communication, and cross-functional collaboration skills.

• Ability to synthesize complex statistical ideas into actionable insights for diverse stakeholders.

• Limited travel required (~10%); primarily remote with periodic in-person meetings.