Senior Biostatistician

$72,700 - $145,300/Yr

Abbott Laboratories - Maple Grove, MN

Full-time - Mid Level

Maple Grove, MN

10,001+ employees

Miscellaneous Manufacturing

About the position

The Senior Biostatistician role at Abbott involves providing statistical expertise in clinical study design, analysis, and reporting within the medical device clinical research organization. This position requires collaboration with clinical study teams to ensure scientific integrity and data quality, while also contributing to the development of statistical analysis plans and reports.

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
• Ensure accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings
• 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 his/her 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.

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 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

Nice-to-haves

• 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
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement and FreeU education benefit
• Training and career development programs
• Paid time off
• 401(k) retirement savings with a generous company match
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs