This position is responsible for biostatistical activities in support of clinical trials including: providing innovative statistical solutions for scientific decision making; preparing statistical analysis plans; writing the statistical section of clinical trial protocols; generating data tables, patient data listings and reports using SAS; performing analysis of clinical trial data, and contributing to the interpretation and presentation of clinical trial data.

This role can sit in Minnesota or Brussels, Belgium.

Your responsibilities will include:

Generates statistical summary tables, patient data listings, and reports using SAS.

Performs quality control check of SAS programs.

Handles complex SAS programming issues as well as all other study programming issues.

Compiles clinical data and relevant background material.

Works with the Clinical Sciences staff to develop scientifically sound clinical study designs and writes the statistical section of clinical research protocols.

Performs sample size calculations or simulations.

Provides input to database requirements and provides SAS dataset specifications.

Prepares the statistical analysis plans.

Performs programming for periodic progress reports for assigned clinical trials.

Assists with the interpretation of clinical trial data and contributes to the Statistical Methods and Results sections of manuscripts and clinical study reports.

What we're looking for in you:

Minimum qualifications

Masters level degree in biostatistics, statistics, or public health preferred; Bachelors level degree will be considered with relevant experience

2+ years of experience in SAS programming; preferably 2 years in medical device or pharmaceutical clinical trials

Demonstrated computer expertise in SAS programming and word processing; experience using SQL and electronic databases highly desirable.

Familiarity with clinical trial design and analysis issues

Preferred qualifications

Ability to think analytically, process scientific and medical data

Ability to work and make decisions independently and understand basic medical information

Good organizational and time management skills

The ability to prioritize and balance work across several projects.

Basic knowledge of regulatory guidelines (FDA/CFR; ENISO14155/GCP/ICH)

Ability to work with minimal supervision

Strong interpersonal communication and presentation skill