Manager,Standards Management Expert (DAS/TFL)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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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: The development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, delivery, analysis & reporting, aligned with program requirements and medical writing. Examples of standard content include supportive documentation to guide and support consistent adoption of standards in clinical trials, standard text, definitions, and analysis requirements that are included in the Protocol and Statistical Analysis Plan, and standard tables, listings and graph mock displays along with detailed analysis requirements and standard analysis rules included in the Data Presentation Specifications.

The role is responsible for acquiring and maintaining deep expertise in the various data collection and analysis tools and templates applied in the clinical trials, specifically those in use in J&J (e.g., AUTOCODE), in industry standards, including but not limited to CDISC standards and adjacent data standards (e.g., HL7 / FHIR, OHDSI/OMOP). The role should be knowledgeable in using common clinical data tools such as LSAF, Pinnacle 21, or SAS. The position may also be involved in innovative projects which require learning of new tools and standards. The role is responsible for remaining aware of the industry standards development and trends, and regulatory requirements, to support the development strategy and evolution of the J&J. The role may also have responsibility for 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 communications 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. Ability to commute to one of the aforementioned office locations.

Benefits: We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Required Skills: Clinical Data Standards, Data Analysis Reporting, Data Collection Methods.

Preferred Skills: Biostatistics, Clinical Data Interchange Standards Consortium (CDISC) Standards, Clinical SAS Programming, Cross-Functional Leadership, Data Management, Regulatory Requirements, Statistical Programming.