Description
DUTIES & RESPONSIBILITIES:Essential duties and responsibilities include the following.
1. Develop, validate and execute programs using SAS for the analysis and reporting of data from clinical trials; program the tables, figures and data listings for interim and exploratory analyses. Provide necessary programming to support scientific manuscripts and meeting presentations.
2. Periodically review and update standards for writing and validating programs according to ICH guidelines.
3. Create sponsor-defined and CDISC (SDTM and ADaM) datasets for statistical programming.
4. Collaborate with study biostatisticians to develop analysis plans for interim, administrative and final statistical analyses and analysis plans for the Integrated Summaries of Safety and Efficacy required for NDA submissions.
5. Participate in program validation activities.
6. Work with biostatisticians and other statistical programmers to create and maintain the SAS programming environment for Biostatistics and Data Management, including SAS macros, SAS includes, SAS format libraries and study-specific dataset libraries.
7. Work with Data Management to conduct QC checks of the database for each study. Participate in the reconciliation of any discrepancies that are found.
8. Provide support to Data Management to conduct QC procedures of the clinical trial database prior to database lock.
9. Participate in establishing standardized templates for Biostatistics and Data Management, such as Safety Database Monitoring Reports and Data Validation and Monitoring Plans.
10. Participate in writing Biostatistics and Data Management SOPs and guidelines.
11. Other duties as assigned. Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
EDUCATION / EXPERIENCE:
Minimum Requirements:
1. A four-year college degree in computer science, statistics or mathematics and 4-6 years experience as a statistical programmer in a biotech or pharmaceutical environment; or a MS degree in Statistics/Biostatistics and at least 4 years of statistical programming experience with clinical trials.
2. Advanced programming skills with SAS (including experience with array processing, SAS/MACRO, SAS/Graph, SAS/ STAT); a working knowledge of different databases (Excel, DataFax a plus) and the ability to migrate data between different database formats.
3. Proficient MS Office Skills (advanced Excel, intermediate Word)
4. Excellent interpersonal skills.
5. Effective communication skills.
6. Effective team participation skills.
Desired:
1. Experience serving on a multidisciplinary team, including development of project plans.
2. Experience with NDA submissions.
3. Experience with Phase III clinical trials.
4. Experience with SDTM and ADaM (CDISC) datasets.
5. Experience with electronic data capture (EDC) systems.
This is a great opportunity to join a leading organization within the field of pharmaceuticals.
To find out more about Real please visit www.realstaffing.com