Statistical Programmer
Job role: Sr. Statistical Programmer
Duration: Long term contract
Location: Remote
Essential Functions:
• Demonstrated ability to independently manage and support multiple global studies simultaneously, with minimal oversight from functional managers.
• Oversee all aspects of programming tasks, including SDTM, ADaM, and TLF preparation performed by vendors, while also managing internal statistical programming activities.
• Collaborate with vendors to ensure programming is accurately created and executed, enabling proper analysis and interpretation for inclusion in reports and regulatory submissions.
• Collaborate with in-house staff by participating in project teams, reviewing protocols, statistical analysis plans, and clinical study reports, and working closely with study statisticians on the project SAP.
• Provide programming support to the DM team, including data reconciliation and related tasks.
• Assist the Head of Statistical Programming and Data Operations (SPDO) in identifying, creating, and maintaining department procedures.
• Contribute to departmental initiatives focused on process improvement and the integration of new technologies.
• Coordinate and collaborate with Japanese colleagues as needed, ensuring alignment on global programming procedures, processes, and standards.
• Proven experience with Base SAS, SAS/STAT, SAS/GRAPH, Reporting and Graphical Procedures, Macro, and SAS Version 9.2 or higher in a clinical trials setting. Knowledge and experience of R and/or Python is a plus.
• Demonstrated experience in submissions programming including data integration (ISS/ISE) and CSR programming.
• Assist in regulatory submissions and have strong experience supporting responses to regulatory authority requests/questions.
• Strong Knowledge/familiarity in FDA/EMA guidances related with Submission in Electronic Format.
• Extensive experience across all phases of clinical development.
• Knowledge/familiarity in ICH/GCP Guidelines and policies.
• Strong Knowledge/familiarity with CDISC CDASH, SDTM/ADaM data structures, vaildation and programming.
• Experience in safety reporting (DSUR/Annual Safety Updates, IB Updates, etc.).
Job Requirements:
Education: M.S. in computer, data science, health science or related discipline required.
Experience:
• Must be a certified clinical SAS professional with more than 8 year extensive experience in pharmaceutical and healthcare industry. SAS experience includes all aspects of dataset creation, data analysis, design, development and implementation of Statistical data models, writing complex macros and reporting in the pharmaceutical industry, and working experience in CDISC Standards and FDA e-SUB regulation requirement. R and/Python knowledge and experience is a plus.
Technical Skills:
• SAS, Proficient in MS Office Suite
Job role: Sr. Statistical Programmer
Duration: Long term contract
Location: Remote
Essential Functions:
• Demonstrated ability to independently manage and support multiple global studies simultaneously, with minimal oversight from functional managers.
• Oversee all aspects of programming tasks, including SDTM, ADaM, and TLF preparation performed by vendors, while also managing internal statistical programming activities.
• Collaborate with vendors to ensure programming is accurately created and executed, enabling proper analysis and interpretation for inclusion in reports and regulatory submissions.
• Collaborate with in-house staff by participating in project teams, reviewing protocols, statistical analysis plans, and clinical study reports, and working closely with study statisticians on the project SAP.
• Provide programming support to the DM team, including data reconciliation and related tasks.
• Assist the Head of Statistical Programming and Data Operations (SPDO) in identifying, creating, and maintaining department procedures.
• Contribute to departmental initiatives focused on process improvement and the integration of new technologies.
• Coordinate and collaborate with Japanese colleagues as needed, ensuring alignment on global programming procedures, processes, and standards.
• Proven experience with Base SAS, SAS/STAT, SAS/GRAPH, Reporting and Graphical Procedures, Macro, and SAS Version 9.2 or higher in a clinical trials setting. Knowledge and experience of R and/or Python is a plus.
• Demonstrated experience in submissions programming including data integration (ISS/ISE) and CSR programming.
• Assist in regulatory submissions and have strong experience supporting responses to regulatory authority requests/questions.
• Strong Knowledge/familiarity in FDA/EMA guidances related with Submission in Electronic Format.
• Extensive experience across all phases of clinical development.
• Knowledge/familiarity in ICH/GCP Guidelines and policies.
• Strong Knowledge/familiarity with CDISC CDASH, SDTM/ADaM data structures, vaildation and programming.
• Experience in safety reporting (DSUR/Annual Safety Updates, IB Updates, etc.).
Job Requirements:
Education: M.S. in computer, data science, health science or related discipline required.
Experience:
• Must be a certified clinical SAS professional with more than 8 year extensive experience in pharmaceutical and healthcare industry. SAS experience includes all aspects of dataset creation, data analysis, design, development and implementation of Statistical data models, writing complex macros and reporting in the pharmaceutical industry, and working experience in CDISC Standards and FDA e-SUB regulation requirement. R and/Python knowledge and experience is a plus.
Technical Skills:
• SAS, Proficient in MS Office Suite
