Statistical Analyst - Medical Devices

2-5 years

$60,000.00 – $120,000.00

Maple Grove Santa Clara

10 March 10, 2025

Job Description

Job Type: Full Time Education: B.S./M.S. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Statistical Analyst - Medical Devices

Category: Medical and Clinical Affairs

About Abbott:
Abbott is a global healthcare leader dedicated to helping people live healthier lives at all stages. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 employees, Abbott operates in more than 160 countries.

Why Work at Abbott?

Career development opportunities in an international company.
Free medical coverage for employees via the Health Investment Plan (HIP) PPO.*
Excellent retirement savings plan with high employer contributions.
Tuition reimbursement and the Freedom 2 Save student debt program.
Recognized as a top workplace for diversity, working mothers, female executives, and scientists.

Location: Maple Grove, MN or Santa Clara, CA (On-Site Role)

The Opportunity:
Abbott Medical Devices is seeking a Statistical Analyst to join the Clinical Research team. This role provides statistical support to the Biostatistics Supervisor/Manager and the Cardiovascular Division (CVD) for clinical studies. Responsibilities include statistical programming, data quality checks, preparing analysis datasets, and generating statistical analysis reports.

Key Responsibilities:

Assist in preparing statistical sections of protocols and writing statistical analysis plans.
Perform sample size and power calculations as needed.
Develop randomization, sampling, and study tools.
Collaborate with clinical study teams to determine data checking needs.
Write and validate SAS programs for reports and data analysis.
Ensure data accuracy by performing quality checks on SAS datasets.
Prepare datasets for statistical analysis and generate summary tables/reports.
Support clinical study teams in data utilization and error identification.
Provide statistical analysis support for publications and investigator projects.
Maintain detailed documentation of statistical methodologies and data inventory.
Support company initiatives related to Quality Management Systems (QMS) and regulatory compliance.
Serve as a backup for other biostatisticians as needed.

Required Qualifications:

Education: M.S. in Statistics, Biostatistics, or related field with 2+ years of experience; or B.S. with 2-5+ years of experience.
Technical Skills: Strong SAS programming expertise is required.
Knowledge of at least one database software package.

Preferred Qualifications:

Advanced degree in Statistics or related field.
2-5+ years of experience in medical device or pharmaceutical clinical research.
Experience in highly regulated environments, including medical device clinical studies.
Ability to work independently and in a team within a fast-paced setting.
Strong verbal and written communication skills.
Ability to multitask, prioritize, and meet deadlines.
Strong organizational skills and attention to detail.

Compensation:

Base salary: $60,000 – $120,000 (Pay may vary based on location).

How to Apply:
Learn more about Abbott’s health and wellness benefits: www.abbottbenefits.com

Abbott is an Equal Opportunity Employer committed to employee diversity.

Connect with Abbott:

Website: www.abbott.com
Facebook: www.facebook.com/Abbott
Twitter: @AbbottNews | @AbbottGlobal

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Statistical Analyst - Medical Devices

Job Description

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