Senior Clinical Programmer
Position Summary
Serving as the subject matter expert for data acquisition, archival, interchange, and reporting of clinical research data, this role leads the development of standards for data collection and transmission and collaborates with cross-functional teams to define therapeutic area standards and data review tools. The Senior Clinical Programmer defines best practices for data acquisition, develops company standards aligned with CDISC conventions and regulatory guidance, and maintains a global library of standard forms, edit checks, reports, and data listings. This role directly contributes to the company's research and development efforts to deliver high-value therapeutics that address unmet medical needs.
Essential Duties & 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.
Qualifications & Experience
- 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.
- Previous people management experience preferred.
- Solid understanding of clinical drug development processes preferred.
Education
Bachelor's degree in Computer Science, Life Sciences, or a related field, or equivalent experience required; advanced degree is a plus.
Additional Information
Nektar currently anticipates the base salary for the Senior Clinical Programmer to range from $160,000 to $185,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience. This position will also be eligible for an 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.) The compensation described above is subject to change and could be higher or lower than the range described based on the market survey data.
Qualifying employees are eligible to participate in benefit programs such as:
- 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)
For general information on company benefits, please go to https://www.nektar.com/careers.