The posting
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Programmer Submission based in the United States.
The Senior Programmer Submission combines hands-on statistical programming expertise with technical leadership across clinical trial studies and regulatory submissions. In this role, you will lead programming activities, ensure the accuracy and quality of clinical datasets and outputs, and support the delivery of compliant submission packages. You will work closely with study statisticians, project managers, and programming teams to coordinate resources, manage deliverables, and resolve technical challenges. The position requires strong knowledge of CDISC standards, SAS programming, and regulatory requirements, with a focus on maintaining high-quality, consistent programming practices. You will also contribute to process improvement, technical training, and the development of reusable programming solutions. This is an opportunity to make a meaningful contribution to clinical research within a collaborative, quality-driven environment.
Accountabilities
- Program and validate clinical datasets and SDTMs, including complex efficacy and laboratory data, ensuring accuracy and compliance with applicable standards.
- Develop complex non-efficacy outputs, tables, figures, and other statistical programming deliverables.
- Perform senior-level reviews and quality control of non-statistical outputs.
- Develop, debug, maintain, and implement complex macros, contributing to the evolution of standard macro libraries.
- Create, review, and update complex dataset specifications for individual and multiple studies, including efficacy datasets and Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) deliverables.
- Review complex study designs and Statistical Analysis Plans (SAPs) independently, assess output shells, and provide technical feedback.
- Apply current SDTM and ADaM standards and ensure appropriate implementation throughout the programming lifecycle.
- Support regulatory submission requirements, including FDA Clinical Data Interchange Standards Consortium (CDISC) requirements and the preparation of define.xml and define.pdf documentation.
- Lead programming teams across multiple studies, taking responsibility for the quality, consistency, and timely delivery of outputs and submission packages.
- Coordinate study-level resources and deliverables with study statisticians and project managers, contributing to resource planning and allocation meetings.
- Act as the primary programming contact for assigned teams, proactively resolving technical issues and maintaining effective collaboration.
- Promote programming best practices across clinical trials and ensure adherence to established quality checklists, standard operating procedures (SOPs), and study documentation requirements.
- Maintain and archive study documentation in accordance with applicable procedures.
- Develop and deliver technical training as required, supporting team capability and continuous professional development.
- Create, review, and update programming processes and SOPs, taking responsibility for compliance at the study level.
- Bachelor's degree or higher in Computer Science, Mathematics, or a related scientific discipline.
- At least five years of SAS programming experience within the pharmaceutical or contract research organization (CRO) industry; this is essential.
- At least five years of experience working with CDISC standards, including programming SDTM and ADaM datasets.
- Strong practical experience with Pinnacle 21 (P21) for clinical data validation.
- Experience with Integrated Summary of Safety (ISS), regulatory submissions, and/or Bioresearch Monitoring (BIMO) activities.
- Solid understanding of clinical trial design, implementation, and common clinical research challenges.
- Familiarity with Good Clinical Practice (GCP) and relevant regulatory requirements.
- Demonstrated ability to lead programming activities across multiple studies while balancing technical delivery, quality assurance, and resource management.
- Strong analytical, problem-solving, and debugging skills, with the ability to review complex programming outputs and specifications independently.
- Effective communication and collaboration skills, including the ability to work with statisticians, project managers, technical teams, and other stakeholders.
- A proactive approach to technical leadership, continuous improvement, documentation, and adherence to quality standards.
- Experience with R programming is preferred.
- Previous regulatory submission experience is preferred.
- Competitive compensation: A competitive salary and benefits package; the specific salary range is not disclosed in the available posting.
- Flexible working arrangements: Remote work is available, with the original posting indicating that candidates can be based anywhere in India.
- Flexible hours: Part-time working hours may be available.
- Training and development: Structured training plans and ongoing opportunities to develop technical and professional skills.
- Continuous learning: Opportunities to build expertise in clinical programming, regulatory submissions, and evolving data science practices.
- Supportive working environment: A collaborative, friendly culture focused on quality, technical excellence, and teamwork.
- Work-life balance: An emphasis on supporting employees in maintaining a healthy balance between work and personal commitments.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
