Senior Programmer

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

📋 Description

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

• Generate intricate non-efficacy outputs and figures.

• Conduct Senior Review and deliver Quality Control of non-statistical outputs.

• Develop and troubleshoot complex macros.

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

• Create, perform Quality Control, and revise complex dataset specifications (including efficacy) for single or multiple studies, as well as ISS/ISEs.

• Review complex study design SAPs independently.

• Review all shells autonomously and provide constructive feedback.

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

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

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

• Familiarize yourself 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 in accordance with the instructions provided in relevant SOPs.

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

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

• Hold accountability for study-level resources.

• Participate in and contribute to company resourcing meetings.

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

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

• Develop and deliver company-wide training as necessary.

• Create, review, and update processes and Standard Operating Procedures (SOPs).

• Ensure compliance with SOPs and processes for studies.

⛳️ Requirements

• A minimum of a BSc degree or higher in Computer Science, Mathematics, or a related scientific discipline.

• Strong experience with Pinnacle 21 (P21).

• Experience in ISS, submissions, and/or BIMO.

• Over 5 years of experience with CDISC standards, specifically programming SDTMs and ADaMs.

• More than 5 years of SAS programming experience within the pharmaceutical or CRO industry (essential).

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

• Familiarity with Good Clinical Practice (GCP) and regulatory requirements.

🏝️ Benefits

• Flexible working arrangements.

• Part-time working hours.

• Structured training and development plans.

• Continuous learning opportunities.

• Competitive salary and benefits package.

• Healthy work-life balance.

• Supportive, fun, and friendly working environment.