Strong programming and logic skills (working knowledge of SAS) * Ability to apply drug development ... Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from ...
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Strong programming and logic skills (working knowledge of SAS) * Ability to apply drug development ... Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from ...
Senior Sdtm Programmer information
What is the role of a statistical programmer?
A statistical programmer, such as a Senior SDTM Programmer, is responsible for developing, validating, and maintaining programming code to analyze clinical trial data according to regulatory standards. They work with statistical analysis plans, create datasets, and generate reports using tools like SAS, ensuring data accuracy and compliance throughout the drug development process.
How much do SAS programmers make?
SAS programmers, including senior SDTM programmers, typically earn between $70,000 and $120,000 annually, depending on experience, location, and industry. Senior roles with specialized skills in clinical data management and regulatory standards often command higher salaries, especially with certifications and proficiency in tools like SAS and CDISC standards.
What is the difference between Senior Sdtm Programmer vs Clinical Data Coordinator?
| Aspect | Senior Sdtm Programmer | Clinical Data Coordinator |
|---|---|---|
| Credentials | Typically requires a degree in life sciences or related field, with experience in SDTM programming | Usually holds a degree in health sciences, nursing, or related field, with data management training |
| Work Environment | Works primarily in clinical trial data programming, using SAS or similar tools | Manages data entry, cleaning, and validation in clinical trial settings |
| Industry Usage | Commonly employed in pharmaceutical and biotech companies for SDTM data standardization | Found in clinical research organizations, hospitals, and pharmaceutical companies |
The main difference is that Senior Sdtm Programmers focus on programming and data standardization using SDTM standards, while Clinical Data Coordinators handle data collection, entry, and quality control. Both roles are essential in clinical trials but differ in technical scope and responsibilities.
Is clinical SAS programmer a good career?
A Senior SDTM Programmer is a specialized role in clinical data management, focusing on programming standards for clinical trial data. It offers steady employment, competitive salaries, and opportunities for advancement, especially with knowledge of SAS, CDISC standards, and regulatory requirements. The role is in demand within the pharmaceutical and biotech industries, making it a viable career choice for those with relevant skills and certifications.
What are the typical collaboration points between a Senior SDTM Programmer and clinical data management teams?
As a Senior SDTM Programmer, you frequently collaborate with clinical data management teams to ensure data collected from clinical trials is accurately mapped and transformed into SDTM-compliant datasets. This often involves clarifying data specifications, resolving data discrepancies, and aligning on timelines for data delivery. Close communication helps maintain data integrity and compliance with regulatory standards, making teamwork and proactive problem-solving crucial aspects of the role.
What are Senior SDTM Programmers?
Senior SDTM Programmers are experienced professionals in clinical data management who specialize in mapping and converting clinical trial data into the Study Data Tabulation Model (SDTM) format according to regulatory requirements. They ensure that data collected during clinical trials is structured, accurate, and compliant with standards set by organizations like the FDA and CDISC. Senior SDTM Programmers often lead programming activities, perform quality control checks, and collaborate with statisticians, data managers, and regulatory teams to prepare submission-ready datasets. Their expertise is vital for successful clinical trial submissions and regulatory approvals.
Are SAS programmers in demand?
SAS programmers, including Senior SDTM Programmers, are in demand in the clinical research and pharmaceutical industries due to their expertise in data management and analysis. Skills in SAS programming, clinical data standards, and regulatory compliance increase employability, especially for roles involving clinical trial data processing and reporting.
What are the key skills and qualifications needed to thrive as a Senior SDTM Programmer, and why are they important?
To excel as a Senior SDTM Programmer, you need deep expertise in clinical data standards (especially CDISC SDTM), advanced SAS programming skills, and a relevant degree in life sciences, statistics, or computer science. Familiarity with clinical trial data management systems, regulatory submission requirements, and tools like Pinnacle 21 are also crucial. Strong attention to detail, problem-solving abilities, and effective communication skills help ensure data accuracy and smooth collaboration with cross-functional teams. These competencies are essential to deliver high-quality, regulatory-compliant datasets that support successful clinical trial submissions.
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Full-time
Posted 3 days ago
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