Senior/Principal Programmer – Data Anonymization

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

📋 Description

• Program and validate datasets and SDTMs, encompassing complex efficacy, labs, and more.

• Develop intricate non-efficacy outputs and figures.

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

• Create and troubleshoot advanced macros.

• Engage in the development of the standard macro library and assume responsibility for implementing standard macros within studies.

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

• Review complex study design SAP independently.

• Evaluate all shells autonomously and offer constructive feedback.

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

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

• Lead the team in the creation of CRT packages.

• Familiarize oneself with and adhere to study documentation.

• Guide a team in advancing programming development.

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

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

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

• Collaborate with the Study Statistician and Project Manager on resourcing and deliverables.

• Oversee study-level resources.

• Participate in and contribute to company resourcing meetings.

• Serve as the primary contact for programming issues within the team, proactively ensuring cohesive operations.

• Advocate for stakeholders to adhere to best practices within trials.

• Develop and provide company-wide training as necessary.

• Create, review, and update processes and SOPs.

• Assume responsibility for study compliance with SOPs and processes.

⛳️ Requirements

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

• Possess SAS Programming experience within the pharmaceutical sector.

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

• Be familiar with GCP and regulatory requirements.

• Experience programming to SDTM and ADaM standards is essential.

• Strong comprehension of clinical trial data flow, from raw datasets to submission-ready formats.

• Have experience across multiple therapeutic areas, having worked on a variety of TAs.

🏝️ Benefits

• PHASTAR is dedicated to upholding the principles and practices of equal opportunities and fostering a diverse workforce.

• Our policy is to employ individuals based on their suitability for the work and their potential for growth, irrespective of age, sex, race, color, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief.

• This commitment includes creating a culture that fully reflects our dedication to equal opportunities for all.