Senior Biostatistician

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 114,000 colleagues serve people in more than 160 countries.

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees
  * via the Health Investment Plan (HIP) PPO.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

We are looking for a Senior Biostatistician for either our Maple Grove, MN, Santa Clara, CA or Burlington, MA locations.

We are seeking an experienced, high caliber Senior Biostatistician to join Abbott’s medical device clinical research organization. This position includes providing statistical expertise in clinical study design, writing statistical analysis plans and reports, performing statistical analysis and programming, checking data quality, preparing analysis datasets, generating and/or validating data listing, and tables/reports. This position will also assist on additional study projects or tasks which may arise.

Working under limited supervision by the statistical manager, provides statistical support to clinical study teams and external teams. This includes:

• Statistical input into clinical study designs, endpoints, hypotheses tests and sample size calculations.
• Performing statistical analysis of clinical study data.
• Validating statistical analyses conducted by statistical peers or colleagues.

This position may also perform statistical analysis or provide statistical input on other projects as assigned by the statistical manager. Able to provide significant input into complex clinical study designs.

Job Duties:

• Provide statistical input into clinical study design, endpoints, hypotheses tests and sample size calculations.
• Write statistical sections of protocols.
• Write statistical analysis plans.
• Provide input into data collection forms (Case Report Forms) and data management plan.
• Provide input on study processes, especially those affecting scientific integrity and data quality.
• Write or provide input into Data Monitoring Committee (DMC) and/or Clinical Events Committee (CEC) charter.
• Ensure scientific integrity and data quality of clinical trials are preserved.
• Participate in DMC meetings as appropriate.
• Prepare statistical reports or statistical sections of clinical study reports.
• Interpret statistical results.
• Generate line listings for regulatory reporting as appropriate.
• Perform validation of statistical analyses conducted by statistical peers or colleagues.
• Ensure accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings.
• Responsible for statistical methods.
• Identify and correct common flaws in interpretation of results, inconsistency in presentation or inference, and adherence to Abbott report guidelines.
• Provide meaningful input to the development of a report strategy.
• Work collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines.
• Provide accurate and timely answers to routine…