Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
At Abbott Molecular, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.
Applies subject matter knowledge.
Requires capacity to understand specific needs or requirements to apply skills/knowledge.
- Provide appropriate statistical input into study design and analysis of data.
- Ensures that statistical sections of protocol-directed clinical studies are designed to establish or validate product performance claims.
- Participates in the preparation of data review and regulatory submissions.
- The Statistician has established a high degree of competence in statistics and programming.
- Responsible for implementing and maintaining the effectiveness of the quality system. Complies with FDA and other regulatory requirements, company policies, operating procedures and task assignments.
- Provides input to study design, protocols, CRFs; creates statistical analysis plans.
- Set up study directory for analysis programming environment.
- Work with data management to set up study data processing.
- Conducts complex data checks, work with data management and clinical affairs to ensure data integrity.
- Performs SAS or R programming to generate tables, figures and data listings for verification study and clinical study records.
- Participates on project teams, be able to communicates the basic stats principal to the project team, acts as the subject matter expert on the team.
- Performs program verification activities, or other related duties on occasion, as assigned.
- Be able to solve simple issues independently.
- Update manager on important issues in a timely manner.
- B.S. Statistics (or related field) + 3 years’ experience
- SAS programming, statistical writing, experience in data analysis
- Master’s degree plus 2 year experience or PhD in Statistics (or related field) is preferred.
- Specific experience in clinical statistics is desirable.
- Familiarity with at least one statistical programming package required; extensive experience with SAS preferred.
- Experience working on medical device studies in highly regulated environment preferred.
- Able to work both independently and as a team member.
- Experience coordination, prioritizing and setting timelines for multiple tasks.
- Good organizational and time management skills.
- Able to communicate effectively, both orally and in writing.
- Able to describe complex procedures concisely and accurately.
- Excellent attention to detail and accuracy
- Statistical Analysis Plans
- Regulatory Requirements
- Communicate Effectively
- Statistical Programming
- Time Management Skills
- Regulatory Submissions
- Subject Matter Expert
- Attention To Detail
- Clinical Affairs
- Company Policies
- Sas Programming
- Data Processing
- Data Management
- Medical Device
- Data Integrity
- Data Analysis
- Project Teams
- Study Design
- Team Member
- Data Review