Senior Biostatistician II (Costa Mesa)

Abbott in Costa Mesa, CA

  • Industry: Pharmaceutical/Biotechnology - Biostatistician
  • Type: Full Time
  • $98,980.00 - 157,700.00
position filled
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.

JOB DESCRIPTION:

We are seeking an experienced, high caliber Senior Biostatistician to join Abbotts 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 (1) statistical input into clinical study designs, endpoints, hypotheses tests and sample size calculations (2) performing statistical analysis of clinical study data (3) 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
  • 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.
  • Job Requirements:

  • 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 strongly desired; 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.
  • Preferred qualifications:

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

  • Associated topics: bioinformatics, biometrics, biostatistics, data analyst, data science, sas, statistics

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