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- Tasks: Lead the development of clinical data standards and ensure compliance with industry best practices.
- Company: Join Cytel, a leader in innovative solutions for clinical trials, supporting top pharmaceutical clients.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Be at the forefront of clinical innovation, impacting patient outcomes through data excellence.
- Qualifications: 10+ years in clinical research with expertise in CDASH, SDTM, ADaM, and regulatory submissions.
- Other info: Engage with cutting-edge technology and contribute to next-gen processes in clinical data management.
The predicted salary is between 48000 - 84000 £ per year.
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you’ll be at the heart of our client’s innovation.
The Associate Director, Clinical Data Standards proactively participates in the development of data and reporting standards in support of the client’s portfolio of clinical trials and ensures conformance to CDISC standards and industry best practices. This role supports the development of strategy and framework for governance of standards and actively engages in deployment of next generation process and technology.
Standards Development responsibilities include:
- Support development of documentation and specifications including business guidance for standard practice for dataset mapping, SDTM, ADaM, and TLFs for study reporting efforts, and associated tool instruction guidelines.
- Contribute to development and review of (draft/existing) SDTM, ADaM, and TLF Standard content to ensure completeness with sufficient content and details for macro implementation.
- Managing the development and maintenance of data management processes and tools.
- Responsible for providing standards guidance and support to the trial team.
- Writing detailed programming specifications for standard rules including creation of standard computational algorithm documents to enhance content in ADaM metadata.
- Development of new standard TLF shells specification and associated annotation of the TLFs with ADaM variables.
- Creation of analysis results metadata (ARM) for TLF standards.
- Work in Pinnacle 21 to test metadata use for define.xml. Review standards metadata and support development of additional standard metadata for define.xml (VLM and derivation logic).
- Understand CDISC standards (including those used for complex data such as RWD, GF and CP) changes and guidance to align when developing business guidance and documentation in support of study teams.
- Develop mappings from RWD to SDTM to extend the CDISC mappings.
- Communicate ongoing standard development activities across the organization.
Minimum Qualifications:
- At least 10 years of relevant clinical research experience.
- Experience leading development of standards for data collection, tabulation, analysis, and/or reporting.
- Experience with CDASH.
- Experience with SDTM, ADaM, & TLF standards is required.
- Knowledge of GXP, FDA, and ICH regulations and industry standards applicable to the design and analysis of clinical trials and regulatory submissions.
- Active participation in CDISC teams.
- Experience with preparing datasets and documentation for regulatory submissions.
- Knowledge of complex data such as RWD, genomics, and cell phenotyping is desired.
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Associate Director Programming, Clinical Data Standards employer: TREIZE-QUARANTE (1340)
Contact Detail:
TREIZE-QUARANTE (1340) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director Programming, Clinical Data Standards
✨Tip Number 1
Make sure to familiarize yourself with the latest CDISC standards and guidelines. Being well-versed in these will not only help you in your role but also demonstrate your commitment to industry best practices during discussions.
✨Tip Number 2
Engage with online communities or forums related to clinical data standards. Networking with professionals in the field can provide insights into current trends and challenges, which you can leverage in your application process.
✨Tip Number 3
Consider reaching out to current or former employees of Cytel to gain a better understanding of the company culture and expectations for the Associate Director role. This insider knowledge can be invaluable during interviews.
✨Tip Number 4
Stay updated on recent advancements in clinical trial methodologies and technologies. Showing that you are proactive about learning and adapting to new processes will set you apart as a candidate who is ready for innovation.
We think you need these skills to ace Associate Director Programming, Clinical Data Standards
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and qualifications required for the Associate Director, Clinical Data Standards position. Tailor your application to highlight your relevant experience in clinical research and standards development.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 10+ years of clinical research experience, particularly focusing on your work with CDASH, SDTM, ADaM, and TLF standards. Provide specific examples of how you've contributed to the development of data and reporting standards in previous roles.
Showcase Technical Skills: Detail your technical skills related to data management processes and tools. Mention any experience you have with Pinnacle 21, metadata testing, and regulatory submissions. This will demonstrate your capability to handle the technical aspects of the role.
Communicate Your Knowledge: Clearly communicate your understanding of CDISC standards and relevant regulations (GXP, FDA, ICH). Discuss any active participation in CDISC teams and how you have kept up with changes in standards, as this is crucial for the role.
How to prepare for a job interview at TREIZE-QUARANTE (1340)
✨Show Your Expertise in CDISC Standards
Make sure to highlight your experience with CDISC standards, especially SDTM, ADaM, and TLF. Be prepared to discuss specific projects where you applied these standards and how they contributed to the success of clinical trials.
✨Demonstrate Leadership in Standards Development
Since this role involves leading the development of data standards, share examples of how you've successfully led teams or initiatives in the past. Discuss your approach to governance and how you ensure compliance with industry best practices.
✨Prepare for Technical Questions
Expect technical questions related to data management processes and tools. Brush up on your knowledge of programming specifications and computational algorithms, as well as your experience with Pinnacle 21 and define.xml.
✨Communicate Effectively
Effective communication is key in this role. Be ready to explain complex concepts in a clear and concise manner. Practice discussing ongoing standard development activities and how you would engage with various stakeholders across the organization.
