Manager, Standards Management Expert (DAS/TFL)

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:

Manager, Standards Management Expert (DAS/TFL) is 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:

• 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
• 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 requires 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

Required Skills:

Clinical Data Standards, Data Analysis 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

Hybrid Work