Principal Statistical Programmer FSP

The Principal Statistical Programmer will develop, maintain, validate and run SAS computer programs that access, visualize, analyze, and report clinical trial or registry data in accordance with statistical analysis plans. Ability to work independently and strong SAS/GRAPH programming experience is required. Ability to comprehend complex programming concepts with minimal guidance is also required.

The position reports to the AD or Director of Statistical Programming.

ShortDescriptionStr

Qualifications

• At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
• Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
• Experience in producing and validating SAS programs;
• Experience in working with CDISC standards, including SDTM, and ADaM;
• Familiarity with statistical analysis for standard clinical trial outputs;
• Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
• Good communications skills required;
• Bachelor's Degree required, Master's Degree Preferred.
• Clear alignment with the Core Values:
• Commitment to People
• Innovation and Discovery
• Sense of Urgency
• Open Culture
• Passion for Excellence

InternalQualificationsStr

Qualifications

• At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
• Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
• Experience in producing and validating SAS programs;
• Experience in working with CDISC standards, including SDTM, and ADaM;
• Familiarity with statistical analysis for standard clinical trial outputs;
• Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
• Good communications skills required;
• Bachelor's Degree required, Master's Degree Preferred.
• Clear alignment with the Core Values:
• Commitment to People
• Innovation and Discovery
• Sense of Urgency
• Open Culture
• Passion for Excellence

InternalResponsibilitiesStr

Key Responsibilities:

• Write SAS programs that produce tables, listings, figures and analysis datasets ;
• Write SAS programs that validate tables, listings, figures, and analysis datasets;
• Follow good programming practices, including adequately documenting SAS code;
• Use, modify, and maintain existing SAS code;
• Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
• Assist in developing programming processes consistent with industry best practices;
• Review DMP, eCRF specs, and other clinical data management documents;
• Review statistical analysis plans and other related documents;
• Partner with CRO to perform any of the above tasks;
• Perform all the tasks with minimal instruction or input from supervisor
• Review, maintain study documents per standard process
• Program, test, and document global utility macros and tools in accordance with standards and validation procedures
• Perform other duties as assigned

Technical and Communication Skills:

• Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. R shiny experience is a plus
• Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
• Excellent and transparent communication skills and ability to represent the functional group to across stakeholders

Comfortable with quick turnaround and able find an optimum solution for a given problem

ExternalResponsibilitiesStr

Key Responsibilities:

• Write SAS programs that produce tables, listings, figures and analysis datasets ;
• Write SAS programs that validate tables, listings, figures, and analysis datasets;
• Follow good programming practices, including adequately documenting SAS code;
• Use, modify, and maintain existing SAS code;
• Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
• Assist in developing programming processes consistent with industry best practices;
• Review DMP, eCRF specs, and other clinical data management documents;
• Review statistical analysis plans and other related documents;
• Partner with CRO to perform any of the above tasks;
• Perform all the tasks with minimal instruction or input from supervisor
• Review, maintain study documents per standard process
• Program, test, and document global utility macros and tools in accordance with standards and validation procedures
• Perform other duties as assigned

Technical and Communication Skills:

• Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. R shiny experience is a plus
• Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
• Excellent and transparent communication skills and ability to represent the functional group to across stakeholders

Comfortable with quick turnaround and able find an optimum solution for a given problem