Job Description
JOB DESCRIPTION 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.
RESPONSIBILITIES Standards Development responsibilities include: - Support development of documentation and specifications including business guidance’s 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 complete 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 specification 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’s to align when developing business guidance’s 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
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
Job Tags
Permanent employment,