Program SDTM datasets and produce related CDISC deliverables such as aCRF, define.xml, reviewer ... Remote #LI-JS1
Program SDTM datasets and produce related CDISC deliverables such as aCRF, define.xml, reviewer ... Remote #LI-JS1
Director, Biostatistics
OR · Remote
Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies #LI-CS1 #LI-Remote
Director, Biostatistics
OR · Remote
Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies #LI-CS1 #LI-Remote
Remote Sdtm information
What is the difference between Remote Sdtm vs Remote Clinical Data Coordinator?
| Aspect | Remote Sdtm | Remote Clinical Data Coordinator |
|---|---|---|
| Certifications | CDISC SDTM, CDMP | CDISC SDTM, CDMP |
| Work Environment | Remote, data management teams | Remote, clinical data management teams |
| Industry Usage | Pharmaceutical, biotech | Pharmaceutical, biotech |
| Primary Responsibilities | Design, validate SDTM datasets | Manage, clean, and verify clinical data |
Remote Sdtm specialists focus on creating and validating SDTM datasets for clinical trials, while Remote Clinical Data Coordinators handle overall data management, including data entry, cleaning, and verification. Both roles require similar certifications and work in the same industry, but their core tasks differ in scope and focus.
How does a Remote SDTM professional typically collaborate with cross-functional teams to ensure accurate clinical data submission?
As a Remote SDTM (Study Data Tabulation Model) professional, you will regularly work with clinical data managers, biostatisticians, and programmers to ensure that clinical trial data is accurately mapped and compliant with regulatory standards. Collaboration often involves virtual meetings, shared documentation, and version control tools to review data mappings and resolve discrepancies. Clear communication and proactive problem-solving are vital, as much of the alignment happens remotely. You'll also participate in data validation and quality control processes to support successful data submissions to regulatory authorities.
What are the key skills and qualifications needed to thrive as a Remote SDTM (Study Data Tabulation Model) Specialist, and why are they important?
To thrive as a Remote SDTM Specialist, you need strong expertise in clinical data management, SDTM standards, and familiarity with regulatory requirements, often supported by a degree in life sciences or a related field. Proficiency in tools like SAS, clinical data management systems (CDMS), and CDISC-compliant software is typically required. Excellent attention to detail, problem-solving abilities, and effective remote communication skills help individuals excel in this role. These competencies ensure accurate data standardization, regulatory compliance, and seamless collaboration within distributed teams.
What is a Remote SDTM professional?
A Remote SDTM (Study Data Tabulation Model) professional is a specialist who works remotely to standardize and organize clinical trial data according to the SDTM guidelines set by the Clinical Data Interchange Standards Consortium (CDISC). This role is crucial in preparing datasets for regulatory submissions by ensuring that data collected in clinical studies is consistently formatted and easily understood. Remote SDTM professionals are responsible for mapping raw clinical data into SDTM domains, performing quality checks, and collaborating with data managers and statisticians. Working remotely allows them to support clinical trials for pharmaceutical or biotechnology companies from anywhere, using secure digital tools.
What are popular job titles related to Remote Sdtm jobs in Oregon? For Remote Sdtm jobs in Oregon, the most frequently searched job titles are:
What job categories do people searching Remote Sdtm jobs in Oregon look for? The top searched job categories for Remote Sdtm jobs in Oregon are:
Full-time
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Job description
Summary
The Senior Clinical Programmer Contractor 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 Senior Manager 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.
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, with some support build and execute programs for internal data reviews, data reconciliation, and edit checks.
- Assist in developing/maintaining clinical programming related standards and tools.
- Work with data management to review case report forms, database specifications and similar documents.
- With some support, 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.
- With minimal supervision, performs stakeholder management, negotiating timelines and scope of deliverables.
- Participate in standards governance and developing biometric department operational processes.
Qualifications
- 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.
- 4+ years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred.
- Good programming experience in SAS.
- Experience with other software languages (e.g., Unix scripts, AI tools, R functions/packages, etc).
- Good knowledge of CDISC data standards (CDASH, SDTM).
- Good 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.
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About Arcus Biosciences
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Hayward, CA, US
Year founded
2015