Senior Biostatistician – Medical Device Clinical Research
Location: Maple Grove, MN | Santa Clara, CA | Burlington, MA | Category: Medical & Clinical Affairs | Employment Type: Full-Time
Company Overview:
Abbott is a global healthcare leader, advancing breakthrough science to improve people’s health at all stages of life. With over 114,000 colleagues serving in more than 160 countries, Abbott provides innovative diagnostics, medical devices, nutritionals, and branded generics that transform patient care.
Role Overview:
Abbott’s Medical Device Clinical Research Organization is seeking an experienced Senior Biostatistician to provide statistical expertise across clinical studies. This role supports study design, statistical analysis, and reporting, ensuring the highest standards of scientific integrity and data quality.
Key Responsibilities:
Provide statistical input into clinical study design, including endpoints, hypothesis tests, and sample size calculations.
Write statistical sections of protocols and develop statistical analysis plans.
Review and provide input on Case Report Forms (CRFs), data management plans, and study processes affecting scientific integrity.
Participate in Data Monitoring Committee (DMC) or Clinical Events Committee (CEC) activities and meetings.
Prepare statistical sections of clinical study reports and regulatory submissions.
Validate statistical analyses conducted by peers, ensuring accuracy, consistency, and compliance with Abbott report standards.
Collaborate with clinical teams, external partners, and peers to develop quality protocols, CRFs, schemas, and reports.
Provide scientific insight and answers to routine and complex statistical queries.
Communicate statistical concepts effectively to scientific and non-scientific stakeholders.
Required Qualifications:
Master’s degree in Statistics or Biostatistics with at least 5 years of relevant experience OR Ph.D. in Statistics or Biostatistics with at least 3 years of experience.
Proven ability to write and describe statistical models of moderate complexity.
Extensive experience with SAS; proficiency in R, WinBUGS, JMP, NCSS, PASS is a plus.
Familiarity with Bayesian and adaptive design methods and data mining techniques is desirable.
Bachelor’s degree with 5+ years of relevant experience may be considered as equivalent.
Preferred Qualifications:
Minimum of 5 years’ experience in medical device clinical research.
Advanced knowledge of clinical study design, statistical methodologies, and regulatory requirements.
Compensation & Benefits:
Base pay: $90,000 – $180,000 (location-dependent).
Abbott offers comprehensive healthcare, retirement, tuition reimbursement, wellness programs, and career development opportunities.
Why Abbott:
Join a global leader in healthcare and medical devices, where you can grow your career, contribute to innovative clinical research, and make a tangible impact on patient outcomes.
Apply Now:
Advance your career as a Senior Biostatistician at Abbott and support cutting-edge medical device clinical research.
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