Senior Statistical Programmer

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

📋 Description

• Program and validate datasets and SDTMs, encompassing intricate efficacy, lab results, and more.

• Develop complex non-efficacy outputs and figures.

• Conduct Senior Review and deliver quality control for non-statistical outputs.

• Create and troubleshoot sophisticated macros.

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

• Generate, quality check, and revise complex dataset specifications (including efficacy) for single or multiple studies, ISS/ISEs, etc.

• Review more complex study design SAPs independently.

• Review all shells autonomously and provide constructive feedback.

• Possess knowledge, interpretation, and implementation of current SDTM and ADaM standards.

• Understand FDA CRT requirements including define.xml and define.pdf.

• Lead the team and take responsibility for the creation of CRT packages.

• Familiarize with and adhere to study documentation.

• Lead a team to enhance programming development.

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

• Archive study documentation according to the instructions provided in the supplied SOPs.

• Act as a Lead Programmer for multiple studies within the same project, ensuring quality and timely delivery.

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

• Manage study-level resources.

• Attend and contribute to company resourcing meetings.

• Serve as the point of contact for programming issues within the team, proactively ensuring cohesive functionality.

• Encourage stakeholders to adhere to best practices within a trial.

• Develop and deliver training on a company-wide level as needed.

• Create, review, and update processes and SOPs.

• Take accountability for study compliance with SOPs and established processes.

⛳️ Requirements

• Hold a BSc or higher in Computer Science, Mathematics, or a related scientific discipline.

• Possess SAS Programming experience in the pharmaceutical sector.

• Have a solid understanding of clinical trial issues, design, and implementation.

• Be familiar with GCP and regulatory requirements.

• Experience in programming to SDTM and ADaM standards is required.

🏝️ Benefits

• Equal opportunities employment.

• A diverse workforce culture.