Senior Programmer – SAS

This is a fully remote position, open to applicants in India.

📋 Description

• Develop and validate datasets and SDTMs, including complex efficacy and lab data.

• Create intricate non-efficacy outputs and figures.

• Execute Senior Review and deliver quality control of non-statistical outputs.

• Design and troubleshoot complex macros.

• Participate in the development of the standard macro library and take charge of implementing standard macros within studies.

• Generate, quality check, and update complex dataset specifications (including efficacy) for individual and multiple studies, as well as ISS/ISEs.

• Review more complex study design SAPs independently.

• Independently review all shells and provide constructive feedback.

• Understand, interpret, and apply current SDTM and ADaM standards.

• Familiarity with FDA CRT requirements, including define.xml and define.pdf.

• Lead the team and oversee the creation of CRT packages.

• Become acquainted with and adhere to study documentation protocols.

• Lead a team to enhance programming development.

• Ensure strict adherence to the principles outlined in the PHASTAR checklist.

• Archive study documentation in accordance with provided SOPs.

• Serve as a Lead Programmer on multiple studies within the same project, ensuring quality and timely project completion.

• Collaborate with the Study Statistician and Project Manager regarding resource allocation and deliverables.

• Manage study-level resources.

• Participate in and contribute to company resourcing meetings.

• Act as the main point of contact for programming-related issues within the team, proactively ensuring seamless operations.

• Influence stakeholders to adhere to best practices throughout trials.

• Develop and deliver training sessions across the company as needed.

• Create, review, and update processes and SOPs.

• Ensure study compliance with SOPs and established processes.

⛳️ Requirements

• Extensive experience in SAS and R (R is mandatory).

• Prior experience in oncology studies is essential.

• Familiarity with R Shiny is preferred.

• Comprehensive end-to-end experience in SDTM and ADaM programming is required.

• Experience in HEOR would be an advantage.

• Proficient in SAS or R programming within pharmaceutical or CRO settings.

• Bachelor’s degree or higher in Computer Science, Mathematics, or a related scientific field.

• Strong SAS programming experience within the pharmaceutical industry.

• Solid understanding of clinical trial design, execution, and implementation.

• Knowledge of GCP and regulatory standards.

• Experience working with CDISC standards (SDTM and ADaM).

🏝️ Benefits

• Remote work options and flexible working hours.

• Opportunities for career development, mentorship, and continuous learning.

• A supportive, friendly, and collaborative work culture.