Senior Biostatistical Programmer/Analyst
Location: Midwest
Responsible
for implementation of SAS programming and biostatistical activities in support of clinical
trials including: generation of data tables, patient data listings and reports using SAS;
preparation of statistical analysis plans; contribute to statistical section of clinical
trial protocols; review and analysis of clinical trial data.
Responsibilities:
Generate statistical
summary tables, patient data listings, and reports using SAS.
Perform quality control
check of SAS programs.
Handle complex SAS
programming issues independently, perform independent database and CRF review to ensure
programming consistency, and be familiar with all study programming issues.
Work with the Biostatistics
Project Manager, in conjunction with Clinical Research staff, to develop scientifically
sound clinical study designs, and contribute to statistical section of clinical research
protocols.
Review CRFs to ensure
consistency with protocol and adequacy in collecting data to meet objectives defined in
protocol.
Under direction of
Biostatistics Project Manager, contribute to or prepare statistical analysis plans.
Prepare template and
programming for periodic progress reports for assigned clinical programs.
Compile clinical data and
relevant back-up material, and present these results to the Biostatistics Project Manager
for review.
Oversee and/or mentor junior
Biostatistical Programmer/Analyst staff, as needed.
Design, test, implement and
document study clinical databases using Oracle Clinical (OC), as necessary.
Establish data validation
rules, as necessary.
Maintain clinical databases
according to change control procedures, as necessary.
Qualifications:
Bachelor's degree in
biostatistics, statistics, or public health; Master's degree preferred.
Minimum of 5 years
experience in clinical research and SAS programming; prefer at least 3 years experience in
medical device or pharmaceutical industry clinical trials.
Demonstrated computer
expertise in SAS programming and word processing; experience using Oracle Clinical and SQL
highly desirable.
Familiarity with clinical
trial design and analysis issues.
Ability to work with minimal
supervision.
Strong interpersonal
communication and presentation skills.
Strong time management,
organizational, and analytical skills.
Ability to work in a
multidisciplinary team.
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