Sr Clinical Programmer

International Executive Service Corps; San Francisco (CA); On-site; USD 160,000 - 185,000; Full time

Benefits offered by this job

Health Insurance (Medical/Dental/Vish)

Disability Insurance

Holiday Pay

Paid Time Off (PTO)

401(k) Match

Employee Stock Purchase Plan

Wellness Programs

Parental Leave Benefits (in accordance

Job summary

Nektar Therapeutics is seeking a Senior Clinical Programmer to join the CDM team, developing and maintaining systems for data acquisition, archival, and reporting across therapeutic areas. You will define CDISC-aligned standards and collaborate with Biostatistics and Clinical Operations to ensure data integrity and regulatory compliance.

You will mentor teammates, oversee EDC development and testing environments, and provide expert guidance on CRF development, data submission, and vendor

Qualifications

• Minimum of 8 years of hands-on, relevant experience in the pharmaceutical or biotechnology industry.
• 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.

Responsibilities

• Lead the development of standards for data collection and transmission across trials.
• Provide leadership for database design, systems development and support, and training activities.
• Serve as EDC and CDISC subject matter expert for clinical study teams.
• Advise on CRF development, validation, and reporting; ensure regulatory-compliant data collection and submission.
• Oversee EDC development and testing environments and vendor qualifications.
• Define regulatory-compliant data exchange standards with CROs, labs, IXRS/IRT, eCOA, and internal teams.
• Mentor team members and drive continuous improvement of CDM processes and tools.

Skills

SAS

Java

C

Spotfire

J-Review

PL/SQL

MySQL

SQL Server

Oracle

Microsoft Office

Education

Bachelor’s degree in Computer Science or Life Sciences

Tools

J-Review

Spotfire

SAS

Java

C

SQL Server

Oracle

MySQL

PL/SQL

Job description

The Sr. Clinical Programmer is an integral member of the CDM team and is responsible for developing, implementing, and maintaining the systems and applications that support CDM and Development Operations across multiple therapeutic areas.

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.

• 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.

• 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.

• 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.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.