Note: The job is a remote job and is open to candidates in USA. Nektar Therapeutics is a company focused on developing high-value therapeutics to address unmet medical needs. The Senior Clinical Programmer serves as a subject matter expert in data acquisition and reporting for clinical research, leading the development of standards and collaborating with cross-functional teams to enhance data collection processes.
Responsibilities
- Address highly complex technical problems requiring analysis of nuanced data and intangible variables; exercise independent judgment in developing methods, techniques, and evaluation criteria
- Provide leadership and direction for database design and programming, systems development and support, and training activities
- Serve as the EDC and CDISC subject matter expert, providing guidance and best practices to clinical study teams
- Advise on standards for CRF development, validation, and reporting; implement and maintain standards for data collection, acquisition, archival, and submission in compliance with CDISC and applicable regulatory guidance
- Oversee EDC development and testing environments; perform functional audits and vendor qualifications
- Develop and maintain global standards and project-specific specifications, including programming and reporting conventions and rules
- Define regulatory-compliant data exchange standards with external partners (CROs, central labs, IXRS/IRT, eCOA) and internal teams (Biostatistics, Clinical Operations)
- Oversee vendor activities across multiple trials to ensure consistency in data collection, transmission, and reporting
- Implement and maintain regulatory-compliant processes for data acquisition, archival, and interchange
- Coordinate with CROs on data collection instruments and reporting tools and establish tracking mechanisms for process- and system-related issues
- Mentor team members and contribute to the continuous improvement of CDM processes, tools, and training
Skills
- Minimum of 8 years of hands-on, relevant experience in the pharmaceutical or biotechnology industry
- Demonstrated experience developing clinical databases (e.g., Medrio, Medidata Rave, Oracle InForm)
- Working knowledge of external data sources (e.g., central labs, IXRS/IRT, eCOA)
- Proficiency in programming and reporting tools such as J-Review, Spotfire, SAS, Java, and C
- Strong experience with relational databases (SQL Server, Oracle, MySQL, PL/SQL)
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint)
- Demonstrated proficiency with ICH, GCDMP, CDISC, and GCP guidelines is required
- Demonstrated ability to solve complex technical problems with innovative solutions
- Strong organizational, project management, and communication skills
- Demonstrated ability to develop processes and training materials
- Self-starter with the ability to mentor others and manage multiple priorities while delivering high-quality work in a dynamic environment
- Bachelor's degree in Computer Science, Life Sciences, or a related field, or equivalent experience required
- Previous people management experience preferred
- Solid understanding of clinical drug development processes preferred
- Advanced degree is a plus
Benefits
- Annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company's discretion on an individual basis.)
- Health Insurance (Medical/Dental/Vision)
- Disability Insurance
- Holiday Pay
- Paid Time Off (PTO)
- 401(k) Match
- Employee Stock Purchase Plan
- Wellness Programs
- Parental Leave Benefits (in accordance with the terms of applicable plans)
Company Overview
Company H1B Sponsorship