Manager, Standards Management Expert (DAS/TFL), Leiden

We are searching for the best talent for a Manager, Standards Management Expert (DAS/TFL) within Integrated Data Analytics&Reporting (IDAR), to provide expert guidance and tailored solutions on projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy. The Standards Management Expert (DAS/TFL) is an individual contributor who takes a leadership role in the collaboration with various internal and external partners to ensure consistency of clinical data standards across clinical trials and in compliance with regulatory requirements.Purpose:

Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization. Manages standards, projects, programs, or processes for Clinical Data Standards in line with agreed internal strategy and regulatory requirements. Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams.Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards. Coaches and trains junior colleagues in clinical data standards application and responsibilities. Integrates Johnson&Johnson's Credo and Leadership Imperatives into team goals and decision making. You will be responsible for:

Developing and maintaining clear specifications for standard content across the data lifecycle, including data collection, delivery, analysis&reporting, aligned with program requirements and medical writing. Providing examples of standard content such as supportive documentation, standard text, definitions, and analysis requirements in the Protocol and Statistical Analysis Plan, and standard tables, listings, and graph mock displays with detailed analysis requirements and rules included in the Data Presentation Specifications.Acquiring and maintaining deep expertise in the various data collection and analysis tools and templates applied in clinical trials, such as AUTOCODE, CDISC standards, HL7 / FHIR, and OHDSI/OMOP. Applying knowledge of common clinical data tools such as LSAF, Pinnacle 21, and SAS. Supporting innovative projects that require learning new tools and standards.Remaining aware of industry standard developments, trends, and regulatory requirements to support the development strategy and evolution of the organization. Providing operational expertise in cross‑functional initiatives. Qualifications / Requirements:

A Bachelor's degree in a scientific, technology, or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD). At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming.Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM). Demonstrated written and verbal communication skills. Demonstrated customer focus and solution‑oriented experience. Demonstrated interpersonal skills to build relationships with internal and external business partners.Demonstrated leadership on cross‑functional projects. Demonstrated leadership in decision making and problem solving. Excellent spoken and written English. Required Skills:

Clinical Data Standards Data Analysis and Reporting Statistical Data Collection Preferred Skills:

Biostatistics Clinical Data Interchange Standards Consortium (CDISC) Standards Clinical SAS Programming Cross‑Functional Leadership Data Management Regulatory Requirements Statistical Programming

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