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Biostatistician
- Insight Global (Irvine, CA)
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Job Description
A large medical device company is looking for a Biostatistician to play a pivotal role in shaping clinical evidence through advance statistical methodologies. This position supports cardiovascular innovations, including heart recovery and atrial fibrillation (AFib) solutions, and contributes directly to improving patient outcomes.
The key responsibilities include but are not limited to:
- clinical trial design and analysis - providing expert statistical input for clinical trial protocols, case report forms (CRFs), and analysis plans.
-Independently develop and execute statistical analysis plans across various study phases.
-Apply statistical and machine learning techniques to large-scale clinical and operational datasets from electrophysiology studies
-Translate complex data into clear, compelling narratives for scientific and business audiences.
Oversee data collection, cleaning, and validation in collaboration with clinical operations.
Maintain documentation and audit trails to ensure inspection readiness.
Support the development of data standards and best practices across the organization.
Partner with R&D, Regulatory, Clinical Affairs, and Marketing to align data strategies with business goals.
Serve as a subject matter expert in data interpretation and evidence generation.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Skills and Requirements
2+ years of experience with biostatistics in a life sciences(clinical trial) or healthcare research environment
Strong experience in SAS and R
Master's Degree PhD - Biostatistics / Epidemiology
Experience with Python
Experience developing statistical analysis plans and writing statistical methods for reports
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