Sr/Principal Statistician (Sponsor-dedicated)

Accountabilities:

• Lead and contribute to statistical activities across the full clinical trial lifecycle, from protocol development through to final clinical study reports.


• Develop Statistical Analysis Plans (SAPs), including mock tables, listings, and figures, ensuring alignment with study objectives and regulatory expectations.


• Provide statistical input into study design, randomization schedules, CRFs, and related clinical documentation to ensure analytical integrity.


• Review and validate programming specifications, datasets, and outputs to ensure accuracy, consistency, and compliance with SAPs and standards.


• Act as a statistical representative on study teams, collaborating closely with clinical, programming, and operational stakeholders.


• Monitor project timelines, manage competing priorities across studies, and ensure timely delivery of statistical outputs.


• Contribute to quality control processes, regulatory submissions, and inspection readiness activities.


• Support mentorship of junior statisticians and contribute to departmental initiatives and process improvements.

Requirements

• Strong academic background in statistics, biostatistics, mathematics, or a related quantitative discipline.


• Extensive experience in clinical trial statistics within pharmaceutical, biotech, or CRO environments.


• Proven expertise in developing SAPs, analyzing clinical trial data, and supporting regulatory submissions.


• Strong understanding of clinical trial methodology, study design, and regulatory requirements (e.g., ICH guidelines).


• Proficiency in statistical programming environments such as SAS or similar tools used in clinical data analysis.


• Experience collaborating with cross-functional clinical teams and supporting sponsor-facing activities.


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


• Excellent communication skills with the ability to explain complex statistical concepts to non-statistical stakeholders.

• Competitive global compensation with performance-based rewards.


• Fully remote working model with international collaboration opportunities.


• Annual learning and development budget to support continuous professional growth.


• Generous paid leave policies and family-friendly benefits.


• Exposure to global clinical trials and high-impact drug development programs.


• Opportunity to work in a scientifically rigorous, innovation-driven environment.


• Travel opportunities for occasional team meetings and industry events.

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