SQL Programmer

As a Clinical SAS + SQL Programmer at Outpace Consulting Services, you will play a crucial role in statistical programming within the clinical domain for a leading ITES company. Your responsibilities will focus on the development and validation of analysis datasets, tables, listings, and figures, ensuring compliance with ICH-GCP guidelines and CDISC standards. Your contributions will be essential for both safety and efficacy parameter analysis in the clinical drug development process.

Key Responsibilities:

• Create derived data specifications in accordance with CDISC SDTM, ADaM, and TLF standards, including those for pooled analysis (ISS/ISE) datasets.
• Perform the development and/or validation of analysis datasets, tables, listings, and figures for safety and efficacy parameters.
• Serve as the project lead for statistical programming projects, understanding and complying with ICH-GCP guidelines, core operating procedures, and work instructions.
• Ensure all programs are compliant with Standard Operating Procedures (SOPs) and project-specific guidelines. Maintain quality and adherence to timelines for all programming-related deliverables.
• Provide support in developing ad hoc reports as required. Develop study-level macros as directed by Senior / Lead Statistical Programmers.
• Track and follow up on all issues raised, escalating unresolved issues to the project point of contact. Communicate any data queries or errors to appropriate team members.
• Regularly update all project-related documentation.
• Handle escalations related to projects.

Qualifications Required:

• Minimum 3 years of experience in the Clinical domain is mandatory.
• Experience in Statistical Programming in the clinical domain.
• Experience and understanding of ICH-GCP principles and the clinical drug development process.
• Proficiency in Clinical SAS programming.
• Proficiency in SQL programming.
• Bachelor's or Master's degree or equivalent in statistics, mathematics, engineering, or a computer-related subject. As a Clinical SAS + SQL Programmer at Outpace Consulting Services, you will play a crucial role in statistical programming within the clinical domain for a leading ITES company. Your responsibilities will focus on the development and validation of analysis datasets, tables, listings, and figures, ensuring compliance with ICH-GCP guidelines and CDISC standards. Your contributions will be essential for both safety and efficacy parameter analysis in the clinical drug development process.

Key Responsibilities:

• Create derived data specifications in accordance with CDISC SDTM, ADaM, and TLF standards, including those for pooled analysis (ISS/ISE) datasets.
• Perform the development and/or validation of analysis datasets, tables, listings, and figures for safety and efficacy parameters.
• Serve as the project lead for statistical programming projects, understanding and complying with ICH-GCP guidelines, core operating procedures, and work instructions.
• Ensure all programs are compliant with Standard Operating Procedures (SOPs) and project-specific guidelines. Maintain quality and adherence to timelines for all programming-related deliverables.
• Provide support in developing ad hoc reports as required. Develop study-level macros as directed by Senior / Lead Statistical Programmers.
• Track and follow up on all issues raised, escalating unresolved issues to the project point of contact. Communicate any data queries or errors to appropriate team members.
• Regularly update all project-related documentation.
• Handle escalations related to projects.

Qualifications Required:

• Minimum 3 years of experience in the Clinical domain is mandatory.
• Experience in Statistical Programming in the clinical domain.
• Experience and understanding of ICH-GCP principles and the clinical drug development process.
• Proficiency in Clinical SAS programming.
• Proficiency in SQL programming.
• Bachelor's or Master's degree or equivalent in statistics, mathematics, engineering, or a computer-related subject.