Job Title: SAS Programmer/Biostatistician (Temporary - 6 months) - 3 openings
FLSA Status: Exempt
Job Number: 10501008
Department: Clinical Development
Description:
The Statistical Programmer will work in conjunction with the biostatisticians and clinicians supporting Phase I - III trials. The individual is responsible for creating, documenting, validating, processing, and maintaining statistical programs that generate analysis datasets, tables, listings and graphics, and as well as support experimental and exploratory analyses of clinical trials across projects.
Essential Duties and Responsibilities:
- Develop program modules (typically using SAS) which can be utilized across therapeutic franchises for data entry, data management, data validation, statistical analyses, statistical report generation and program validation;
- Write programs to analyze data with statistical methods which are not currently available through commercial software packages;
- Develop tools to retrieve large amounts of data from available databases, merge them, and place the data into SAS or other types of analyzable data files;
- Produce statistical output for clinical study reports, manuscripts, abstracts, and regulatory/health authority submissions, using primarily SAS;
- Validate statistical programs and output for clinical study reports, manuscripts, abstracts, and regulatory/health authority submissions;
- Ensure compliance with applicable standards and practices.
Job Requirements:
Education: Bachelors degree with 4+ years of relevant experience or a Masters degree with 2+ years of relevant experience involving statistical programming in the clinical trials environment.
Experience: Strong knowledge of programming techniques and experience with SAS, regulatory submissions (NDA, CTD, etc.), and analytical ability.
Specific Skills:
- Basic understanding of statistical terminology and concepts resulting in effective interaction with biostatisticians;
- Able to comprehend statistical analysis plans and SAS manuals which describe statistical methodology to be programmed;
- Strong interpersonal skills with the ability to work in a team setting;
- Flexible and able to adapt to changing conditions in a fast-paced environment;
- Strong oral and written communication skills;
- Sound professional judgment.
- Formal statistical training is highly desired but is not required;
- Able to identify problems as well as propose and implement solutions;
- Strong project and time management skills.
Supervisory Responsibilities: None.
Physical Demands/Work Environment: This position will require approximately 80% of time spent in an office environment sitting at a computer. Activities comprising the remaining 20% (meetings, conferences, co-worker interactions) will require moving between offices and buildings on the Arena campus and some travel.
