Senior Biostatistician

The Opportunity

We are seeking an experienced, high caliber Senior Biostatistician to join Abbott’s medicaldeviceclinical research organization. This position includes providing statistical expertise in clinicalstudy design, writing statistical analysis plans and reports, performing statistical analysis andprogramming, checking data quality, preparing analysis datasets,generatingand/or validatingdata listing, and tables/reports. This position will also assist on additional study projects or taskswhich may arise.

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

• statistical input into clinical study designs, endpoints, hypotheses tests and samplesize 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 asassigned by the statistical manager. Able to provide significant input into complex clinical studydesigns

WhatYou’llWork On

Job Duties:

• Provide statistical input into clinical study design, endpoints, hypotheses tests andsample size calculations

• Write statistical sections of protocols

• Write statistical analysis plans

• Provide input into data collection forms (Case Report Forms) and data managementplan

• Provide input on study processes, especially those affecting scientific integrity anddata quality

• Write or provide input into Data Monitoring Committee (DMC) and/or Clinical EventsCommittee (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

• Ensures accuracy of report text and consistency between summary tables in the bodyof reports and the corresponding statistical tables and listings.

• Responsible for statistical methods

• Identifiesand corrects common flaws in interpretation of results, inconsistency inpresentation or inference, and adherence to Abbott report guidelines.

• Provides meaningful input to the development of a report strategy.

• Works collaboratively with peers to develop quality protocols, CRF, schema, andreports per agreed timelines.

• Providesaccurateandtimelyanswers to routine questions from clients, scientificinsight when answering nonstandard questions, and independently pursues analysessuggested by the data.

• Communicates an understanding of basic clinical principles for his/her project andactsin accordance withthose principles.

• Can clearly communicate basic statistical concepts to other scientists andnonscientists. Informs supervisor or manager onimportant issuesin a timely manner.

Required Qualifications:

• Masters in statistics or biostatistics with a minimum of 5 years of experience or Ph.D. in statistics or biostatistics with 3 years of experience.

• Able to write/describe statistical models of moderate complexity.

• Extensive experience with SAS isrequired; experience with R,Winbugs, JMP, NCSSPASSand other statistical software are a plus.

• Knowledge of Bayesian and/or adaptive design methods and data mining are a plus.

• BachelorsDegree (± 16 years), BS/BA with 5+ years related work experience OR an equivalent combination of education and work experience,

• MastersDegree (± 18 years), MS with 3+ years of related work experience OR an equivalent combination of education and work experience

Preferred Qualifications:

• Able to write/describe statistical models of moderate complexity.

• Extensive experience with SAS is required; experience with R, Winbugs, JMP, NCSSPASS and other statistical software are a plus.

• Knowledge of Bayesian and/or adaptive design methods and data mining are a plus.

• Minimum of 5 years of experience in medical device Clinical Research role ispreferred.

WHAT WEOFFER:

At Abbott, you can have a good job that can grow intoa greatcareer.We offer:

• A fast-paced work environment where your safety is our priority

• Training and career development, with onboarding programs for new employees andtuitionassistance

• Financial security through competitive compensation,incentivesand retirement plans

• Health care and well-being programs including medical, dental, vision,wellnessandoccupational health programs

• Paid time off

• 401(k) retirement savings with a generous company match

• The stability of a company with a record of strong financial performance and history ofbeing actively involved in local communities

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