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Principal Statistician– Late Phase- Cardiovascular, Renal, and Metabolism (CVRM)-(REMOTE)
Posted about 1 month agoViewed
💎 Seniority level: Principal, Significant experience
🔍 Industry: Pharmaceutical/Healthcare
🏢 Company: ClinChoice
🗣️ Languages: English
⏳ Experience: Significant experience
Requirements:
- MSc/PhD in Statistics or Mathematics (with a strong statistical focus) and significant experience in pharmaceutical/healthcare statistics or related fields.
- Proven leadership capabilities to direct cross-functional teams and manage complex projects.
- Extensive experience in data analysis and statistical interpretation in clinical trials, with a deep understanding of regulatory and technical requirements.
- High proficiency in statistical programming (e.g., R and/or SAS), with a track record of applying these skills in drug development.
- Strong collaboration skills, with the energy to work across global, cross-functional teams and external partners.
- Experience in program and study design for clinical trials, particularly in early-stage clinical development.
- Knowledge or experience in the Cardiovascular, Renal, and Metabolism (CVRM) therapeutic areas.
- Experience with regulatory interactions, including presenting statistical findings and answering queries from regulatory bodies.
Responsibilities:
- Lead statistical thinking within cross-functional teams, contributing significantly to early clinical development in the CVRM area.
- Drive strategic planning and quantitative decision-making across drug development programs, ensuring robust statistical methodology is applied throughout.
- Oversee delivery of statistical support on drug projects and studies, ensuring high quality, timeliness, and adherence to standards, collaborating with CROs and Programming teams as needed.
- Lead methodological innovation by adapting or developing new statistical methodologies for early clinical trials, advancing the field through creative solutions.
- Develop and implement new procedures and standards aimed at increasing efficiency, quality, and effectiveness across clinical development.
- Acting as a subject matter expert in statistical methodologies, liaising with external collaborators and regulatory agencies.
- Mentoring junior staff and fostering the development of talent by providing guidance, training, and support in statistical techniques.
- Engaging with regulatory agencies, participating in meetings, and addressing statistical queries during regulatory submissions.
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