Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas. * Understand the various tools that we work with * High level ...
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Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas. * Understand the various tools that we work with * High level ...
Cdisc Sdtm Adam information
What are CDISC SDTM and ADaM?
CDISC SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) are data standards used in clinical trials to organize and submit data to regulatory agencies like the FDA. SDTM defines how to structure raw clinical trial data for submission, focusing on standardizing data tabulation. ADaM provides guidelines for creating datasets used in statistical analysis, ensuring the data is analysis-ready and traceable back to SDTM. Both standards improve data quality, consistency, and regulatory review efficiency in the pharmaceutical industry.
What are the typical collaboration points between a CDISC SDTM/ADaM programmer and clinical data managers during a clinical trial project?
A CDISC SDTM/ADaM programmer works closely with clinical data managers to ensure data collected during a clinical trial is accurately mapped and transformed according to regulatory standards. Collaboration often involves clarifying data definitions, resolving data discrepancies, and aligning on timelines for data delivery. Regular meetings and clear communication are key, as programmers rely on data managers for clean, validated data, while data managers depend on programmers to structure data sets correctly for analysis and regulatory submission. This partnership is essential for meeting project deadlines and maintaining data integrity.
What are the key skills and qualifications needed to thrive as a CDISC SDTM/ADaM specialist, and why are they important?
To thrive as a CDISC SDTM/ADaM Specialist, you need a solid background in clinical data management, knowledge of regulatory standards, and expertise in statistical programming (often with SAS). Familiarity with CDISC SDTM and ADaM models, FDA submission requirements, and tools like Pinnacle 21 or JReview is typically required. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for this role. These competencies ensure accurate data standardization, regulatory compliance, and smooth collaboration in clinical research environments.
What is the difference between Cdisc Sdtm Adam vs Clinical Data Coordinator?
| Aspect | Cdisc Sdtm Adam | Clinical Data Coordinator |
|---|---|---|
| Primary Role | Develops and manages ADaM datasets for clinical trials | Oversees data collection, entry, and quality control in clinical studies |
| Required Skills | Knowledge of CDISC standards, SAS programming, statistical concepts | Data management, database systems, attention to detail |
| Work Environment | Pharmaceutical or CRO data analysis teams | Clinical research sites, CROs, pharmaceutical companies |
While Cdisc Sdtm Adam specialists focus on creating analysis datasets using CDISC standards, Clinical Data Coordinators manage the overall data collection and quality in clinical trials. Both roles require knowledge of clinical data processes but differ in their specific responsibilities and technical focus.
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Job description
About MMS
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.
Senior Biostatistician:
Responsibilities:
- Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.
- Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.
- Review ADAM and TLFs; work with client and programmers to resolve comments.
- Strong programming and logic skills (working knowledge of SAS)
- Ability to apply drug development knowledge during production of high quality statistical analyses.
- Perform sample size calculations for a variety of scenarios and study designs.
- Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.
- Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas.
- Understand the various tools that we work with
- High level knowledge of drug development as it pertains to biostatistics.
- Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.
- Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support
- High proficiency with MS Office applications
- Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation.
- Provide ICH guideline based input as applicable to statistics.
- Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.
- College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.
- Minimum of 5 years’ experience in Biostatistics or similar field required.
- Expert knowledge of scientific principles and concepts.
- Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses.
- Strong SAS programming, SAS base, SAS macro experience.
- Thorough knowledge and understanding of clinical data preferred.
- Strong experience with data and production of TLGs.
- Excellent scientific writing skills.
- Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.
- Proficiency with MS Office applications.
- Hands-on experience with clinical trial and pharmaceutical development preferred.
- Good communication skills and willingness to work with others to clearly understand needs and solve problems.
- Excellent problem-solving skills.
- Good organizational and communication skills.
- Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
- Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.
Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.
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About M. M. S.
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
1 - 10 Employees
Headquarters location
Los Angeles, CA, US
Year founded
1980