Senior Biostatistician
$78k - $156kAbbott Laboratories
Senior Biostatistician – Abbott Location: Maple Grove, MN; Santa Clara, CA; Burlington, MA. Position: Onsite daily role. The Opportunity We are seeking an experienced, high‑caliber Senior Biostatistician to join Abbott’s medical device clinical research organization. This role involves 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 validating data listings, tables, and reports, and assisting on additional study projects as needed. Key Responsibilities Statistical input into clinical study designs, endpoints, hypothesis tests, and sample size calculations. Performing statistical analysis of clinical study data. Validating statistical analyses conducted by peers or colleagues. Providing significant input into complex clinical study designs. Providing statistical input on additional projects as assigned by the statistical manager. Job Duties 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 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 questions from clients, scientific insight when answering nonstandard questions, and independently pursue analyses suggested by the data. Communicate an understanding of basic clinical principles for the project and act in accordance with those principles. Clearly communicate basic statistical concepts to other scientists and nonscientists. Inform supervisor or manager on important issues in 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 and describe statistical models of moderate complexity. Extensive experience with SAS 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 is a plus.
- Bachelor’s Degree (± 16 years) with 5+ years related work experience or an equivalent combination of education and work experience.
- Master’s Degree (± 18 years) with 3+ years of related work experience or an equivalent combination of education and work experience.
$78k - $156k
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