Clinical Data Senior Clinical Data Programmer - REMOTE South San Francisco, California
Orbis Clinical is seeking a remote-based Senior Clinical Data Programmer for 12+ months.
As a Contract Senior Clinical Data Programmer, you will play a key role in providing expertise and oversight to ensure complete, accurate and high-quality outputs for internal, cross-functional data review. In addition, you will provide support within the organization to contribute to clinical data programming standards and processes. You should enjoy working with a dynamic and multi-disciplinary team and be able to work independently and collaboratively with both key functions internally and externally.
What you’ll do:
- Design, program, and validate clinical trial reports, listings, and visualizations using tools such as SAS, R, or Python.
- Collaborate with stakeholders to understand the scope of work, requirements, plan, and execute deliverables in collaboration with data managers, clinical programmers, and management while adhering to established timelines.
- Demonstrated experience in programming, testing and validating programs and reports after development, ensuring accuracy, reliability, and compliance with regulatory and organizational standards.
- Strong ability to document specifications, validation processes and results, maintaining comprehensive records.
- Proven ability to support clinical review processes through the development, validation, and maintenance of robust, reliable, and innovative programming solutions.
- Experience with quality assurance processes and methodologies within clinical data management, including knowledge of Good Clinical Practice (GCP) and other relevant regulatory guidelines.
- A deep understanding of the importance of data integrity in clinical trials, with the ability to design and implement processes that ensure the consistency, accuracy, and reliability of clinical data throughout the trial lifecycle.
- Experience with automation tools and techniques to improve the efficiency of clinical programming tasks, including the testing and validation phases. Familiarity with scripting and automation in R, Python, or SAS is a plus.
- Serve as a technical resource for the programming group, providing guidance on complex programming tasks, standards, and processes.
- In-depth knowledge of industry regulations and standards, including 21 CFR Part 11, CDISC (Clinical Data Interchange Standards Consortium), and ICH guidelines, with the ability to ensure all programming activities are compliant.
- Experience with version control systems and change management processes, ensuring that all changes to programming code and datasets are tracked, documented, and controlled.
- Excellent communication skills, with the ability to clearly document programming activities, testing results, and validation processes, and effectively communicate findings and recommendations to both technical and non-technical stakeholders.
- Participate in project management cross-functional teams that work on standard operating procedures, guidelines, process improvements, system validation and acquisition, customization and integration of new tools and technologies.
Requirements:
- Bachelor’s degree in Statistics, Life Sciences, Computer Sciences, Mathematics, or related field with at least 10 years of experience in clinical programming.
- Proficiency in R or Python and/or SAS programming skills within a clinical data environment, with excellent analytical skills. Knowledge of other programming languages is a plus.
- Understanding of pharmaceutical clinical development, including statistical concepts, techniques, and clinical trial principles, as well as knowledge of regulatory submissions and requirements.
- Ability to collaborate effectively on global interdisciplinary teams with strong organizational, interpersonal, communication, and leadership skills. Establish and maintain effective working relationships with coworkers, managers, and clients.
- Veeva CDMS experience is a plus.
- Demonstrated capability to manage multiple tasks and projects efficiently.
- Strong problem-solving and innovative skills, demonstrating initiative and motivation.
- Ability to influence others, mentor, and coach junior programmers to achieve exceptional results.
- Experience establishing, organizing and standardized infrastructure for clinical reporting
Compensation Details:
- Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $85-$95 per hour, can vary depending on employment status.
- Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
