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Abbott · 2 days ago

Senior Biostatistician

Santa Clara, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $180K/yr

3+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a Senior Biostatistician to provide statistical expertise in clinical study design, perform statistical analysis, and ensure data quality in clinical trials. The role involves collaborating with clinical study teams and contributing to the development of statistical reports and protocols.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

Ensures 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

Identifies and corrects common flaws in interpretation of results, inconsistency in presentation 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, and reports per agreed timelines

Provides accurate and timely answers to routine questions from clients, scientific insight when answering nonstandard questions, and independently pursues analyses suggested by the data

Communicates an understanding of basic clinical principles for his/her project and acts in accordance with those principles

Can clearly communicate basic statistical concepts to other scientists and nonscientists. Informs supervisor or manager on important issues in a timely manner

Qualification

SASBiostatisticsClinical ResearchStatistical AnalysisStatistical ModelsRWinbugsJMPNCSS PASSBayesian MethodsData Mining

Required

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 is required; experience with R, Winbugs, JMP, NCSS PASS and other statistical software are a plus

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

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

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

Preferred

Able to write/describe statistical models of moderate complexity

Extensive experience with SAS is required; experience with R, Winbugs, JMP, NCSS PASS 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 is preferred

Benefits

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 fast-paced work environment where your safety is our priority

Training and career development, with onboarding programs for new employees and tuition assistance

Financial security through competitive compensation, incentives and retirement plans

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

Paid time off

401(k) retirement savings with a generous company match

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.