Professional Consulting
About the Role
Summary:
The Senior Programmer of Data Standards & Statistical Programming will develop and validate SAS programs for clinical trial data, including SDTM and ADaM datasets. This role involves collaborating with biometrics, creating SAS macros, and ensuring adherence to departmental standards for data outputs and Define.xml files.
Responsibilities:
+ Conduct statistical programming for diverse clinical studies.
+ Deliver accurate datasets and analysis results within project deadlines.
+ Partner with statistical programmers, data managers, and biostatisticians for seamless project execution.
+ Design and implement SAS macros to streamline and optimize results production.
+ Perform statistical analyses to support the interpretation of clinical trial outcomes.
+ Develop, validate, and deliver CDISC-compliant datasets, SAS transport files, Define.xml, Pinnacle 21
reports, and reviewer guides.
+ Produce safety and efficacy tables, listings, and graphs using SAS for clear data visualization.
+ Review and provide feedback on statistical analysis plans, dataset specifications, and other relevant trial
documents.
+ Detect and rectify data discrepancies to ensure data integrity.
Requirements
Bachelor's or Master's degree in mathematics, statistics, computer science, or a related field.
Over 8 years of experience in statistical programming within the bio-pharma sector utilizing SAS.
Over 5 years of experience with CDISC SDTM and ADaM standards.
Experience in oncology clinical trials, ideally with RECIST criteria.
Experience developing datasets and outputs for regulatory filings.
Over two years of experience in a dynamic small or medium biotech setting.
Extensive understanding of SAS programming.
Familiarity with R or Python is beneficial.
Preference is given to Green Card holders, U.S. citizens, or those with an H4 EAD.
About the Company