Responsibilities:
- Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).
- Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets.
- Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
- Provides input in the design and development of case report forms and clinical databases.
- Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
- Programs for quality checks for clinical study raw data and report the findings to Data Management.
- Provides input in the design and development of case report forms and clinical study databases.
- Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming.
Requirements:
- MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years.
- Experience in providing statistical programming support to early and late phase clinical trials.
- Excellent skills in SAS programming and statistical reporting.
- Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
- Familiarity with FDA and ICH regulations and guidelines.
- Excellent problem-solving skills.
- Good written and verbal communication skills and organizational and documentation skills.
- Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
- Ability to prioritize and multi-task effectively.
- Demonstrated positive attitude and the ability to work well with others.
All your information will be kept confidential according to EEO guidelines.
