Responsibilities:
* Develop targeted, study-specific SDTM and Adam dataset checks
* Perform independent QC, from raw data to Adam, of primary and key secondary endpoints
* Deliver programming results for ad-hoc analysis requests
* Collaborate with data management and their programming team to ensure appropriate data collection and reporting
* Participate in study team meeting and support statistician operational activities
* Assist in efforts to identify, develop, and implement departmental standards, applications, processes and training
Requirements:
* Master's degree in biostatistics/statistics/public health or similar field.
* Basic understanding of clinical trials.
* Working knowledge of SAS, including complex data manipulation and basic analysis procedures; or certifications for SAS programming.
* Excellent verbal and written communication skills.
* Familiarity with CDISC standards, derivation of SDTM and ADaM specifications.
* Simulations and sample size calculation.
* Proficiency in R.