Senior Manager, Statistical Science - REMOTE

Proclinical is seeking a remote Senior Manager, Statistical Science for a global biotech company.

As a Statistical Science Study Lead, the Senior Manager oversees and manages Statistical Science activities for one or more studies to ensure timely and high-quality deliverables. This role involves providing statistical leadership, collaborating on study design, data analysis, and ensuring Data Science deliverables.

Must be eligible to work in the US.

Job Responsibilities:

• Develop the statistical analysis plan (SAP), including endpoint definition, sample size justification, and statistical methodology.
• Lead and oversee statistical analysis activities, ensuring the quality of deliverables.
• Collaborate on study design and contribute to study-related documents.
• Manage study timelines and resource needs.
• Serve as the study's statistical expert and ensure result accuracy.
• Analyze and interpret clinical study data.
• Identify and manage issues and escalate as needed.
• Stay updated on relevant advancements in science and technology.
• Develop process documents and templates.
• Represent Statistical Science and Data Science guidance in cross-functional study teams.
• Prepare for regulatory agency meetings and provide statistical leadership for marketing applications.
• Ensure data quality and analysis accuracy in regulatory interactions and publications.

Skills and Requirements:

• PhD preferred, or MS in statistics, biostatistics, or a related discipline.
• 3+ years of clinical trial experience with a PhD; 6+ years with an MS.
• Experience with statistical analysis plans, study protocols, clinical study reports, safety and efficacy reports, Investigator Brochures, and regulatory submissions.
• Strong programming skills in SAS, R, and other statistical software

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at +(1) 305-929-0913 or p.bonilla@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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