Principal Clinical Programmer (Office OR Remote)
Hayward, California, United States; Brisbane, California, United States; United States
The Principal Clinical Programmer will be responsible for support of team data review, data reconciliation and edit checks, and programming submission ready SDTM deliverables. This position will report to a Director of Clinical Programming or higher and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members. Demonstrated ability to prioritize work and to effectively communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.
This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility and scientific curiosity useful for establishing internal infrastructure, developing analysis standards, and driving both formal and exploratory work. Responsibilities:
This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility and scientific curiosity useful for establishing internal infrastructure, developing analysis standards, and driving both formal and exploratory work. Responsibilities:
- Working from specifications developed by Data Management, independently build and execute programs for internal data reviews, data reconciliation, and edit checks.
- Lead in the development and maintenance of clinical programming related standards and tools.
- Work with data management to review case report forms, database specifications and similar documents.
- Independently develop data transfer specifications and manage the transfer of external data.
- Program SDTM datasets and produce related CDISC deliverables such as aCRF, define.xml, reviewer’s guide, etc.
- Performs stakeholder management, negotiating timelines and scope of deliverables.
- Participate in standards governance and developing biometric department operational processes.
- Mentor Clinical Programming staff as needed.
- Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
- Minimum 6+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred.
- Advanced programming experience in SAS. Experience working with other languages (R) in validated environments is a plus.
- Solid, demonstrated experience with CDISC data standards (CDASH, SDTM).
- In-depth knowledge of data standards and demonstrated experience in the handling of non-CRF data including proven ability to work with diverse data types, such as biomarker, PK/PD, pharmacovigilance, etc.
- Demonstrated ability to rapidly adapt to changing project and strategic requirements.
- Takes a fit-for-purpose mindset to daily work as well as long-term vision.
Job Profile
Regions
Countries
- Build and execute programs
- Develop and maintain programming standards
- Develop data transfer specifications
- Mentor staff
- Program SDTM datasets
- Review case report forms
- Stakeholder management
Biostatistics CDASH CDISC Clinical Programming Data Management Data reconciliation Data Review Mentoring Programming Standards R SAS SDTM Stakeholder management
Experience6 years
Education TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9
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