Senior Manager, Statistical Science - REMOTE
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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.
- 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 firstname.lastname@example.org.
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.