ZipRecruiter

Log In

2

Remote Sdtm Jobs in Oregon (NOW HIRING)

All JobsSdtm JobsRemote Sdtm JobsRemote Sdtm Jobs in Oregon

Remote Sdtm information

What is the difference between Remote Sdtm vs Remote Clinical Data Coordinator?

AspectRemote SdtmRemote Clinical Data Coordinator
CertificationsCDISC SDTM, CDMPCDISC SDTM, CDMP
Work EnvironmentRemote, data management teamsRemote, clinical data management teams
Industry UsagePharmaceutical, biotechPharmaceutical, biotech
Primary ResponsibilitiesDesign, validate SDTM datasetsManage, 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:
Remote Sdtm jobs near you
Director, Biostatistics

Director, Biostatistics

Ultragenyx Pharmaceutical

OR • Remote

Other

Posted 9 days ago

Job description

Position Summary:

ultracurious - Apply your biggest ideas in courageous ways

The Director of Biostatistics acts as program statistical lead; provides technical leadership and biostatistical support on the design and conduct of clinical studies; participates in the evaluation, interpretation, and reporting of study results, in regulatory submissions to the FDA and other regulatory agencies; performs statistical analyses and develops tracking systems for data quality assurance. 

The Director of Biostatistics contributes to identifying, developing, and implementing departmental standards, applications, processes, and training. Provides timely support to the project teams on all statistical matters according to the project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level. 

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:
  1. Lead in product / indication level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective 
  2. Contribute to study level tasks from statistics perspective, including: study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TFL shell and specification Review CRFs and other study documentations; Active participation in study related meetings 
  3. Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting 
  4. Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements 
  5. Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results 
  6. Contribute to developing standards and research in advanced statistical methodologies 
  7. Author/review regulatory documents or scientific publications 
  8. Mentor junior team members 
Requirements:
  1. PhD in Statistics or Biostatistics with a minimum of 8 years (min 11 years for Masters) of post-graduate experience in the clinical trials setting in the pharmaceutical industry 
  2. Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction 
  3. Experienced as product lead statistician and contributing to strategy discussion in cross functional settings; Experienced in managing multiple products and studies and being able to prioritize 
  4. Experienced in study level work including authoring SAP and TFL specification 
  5. Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance 
  6. Solid understanding of mathematical and statistical principles; Experience in statistical methods analyzing longitudinal data is preferred 
  7. Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline 
  8. Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies 

#LI-CS1 #LI-Remote

Apply