J&J Family of Companies Clinical Analysis Standards Expert - Programming in Beerse, Belgium

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Analysis Standards Expert / Programming to be based in Beerse, Belgium.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.

We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more.

The Clinical Analysis Standards Expert for Programming partners with cross-functional stakeholders to drive and facilitate the utilization of standards to improve the efficiency of clinical research analysis and reporting processes and improve the consistency, quality, compliance, and value of clinical trial information. The Clinical Analysis Standards Expert serves as the single point of contact for statistical programming stakeholders in activities pertaining to Analysis Standards. The Clinical Analysis Standards Expert co-leads cross-functional subject matter experts (SMEs) in the development and maintenance of requirements for global and disease area analysis standards while providing expert guidance regarding industry standards and relevant regulatory requirements. To facilitate adoption, the Clinical Analysis Standards Expert will drive the development and maintenance of requirements for a data lifecycle plan (DLP) which documents the standard data collection, analysis and reporting strategy and content for defined compound development programs.

Responsibilities

  • With Data Collection Standards Experts, drives the development of requirements for the DLP with cross-functional SMEs. Works with Regulatory Intelligence to ensure alignment with the Study Data Standardization Plan.

  • Work with statistics and statistical programming SMEs to document requirements for ADaM dataset design to address the requirements described in the standard protocol, SAP, and mock displays.

  • Coordinates review and acceptance of the DLP by functional SMEs.

  • Facilitates periodic review of the DLP by cross-functional SMEs to ensure alignment with evolving science and business needs approximately annually and/or as compounds progress through their development lifecycle.

  • With other Clinical Development Standards (CDS) functions, defines the process for the development, governance, and maintenance of the integrated, end-to-end standards content.

  • Communicates requirements to Integrated Standards and Analytics who will build and QC the ADaM metadata for conformance with Janssen business rules, industry standards, and regulatory requirements.

  • Coordinates the scientific review and acceptance by statistical programming SMEs of standard ADaM metadata, SAS macros, programs, and test output to ensure they are consistent with requirements and fit for purpose.

  • Partner with functional SMEs to provide training to internal and external users on standards principles and concepts such as end-to-end traceability and interoperability, topic-specific standards, how to use the DLP, how to implement standards in specific trial deliverables (eg, ADaM design, analysis dataset creation, generating displays of study results).

  • Partners with functional SMEs to drive the study-level use of the DLP to ensure optimal adoption of and conformance to standards.

  • Partner with Clinical Development Standards and business functions to define meaningful metrics assessing standards adoption, conformance, regulatory compliance, and value.

  • Evaluate metrics reports, review with CDS, functional SMEs and management, identify and take action as needed to increase the value of standards to the organization.

  • Develop and maintain expertise in relevant industry standards (eg, protocol, ADaM, controlled terminology).

  • Participate in industry standards development directly (eg, CDISC, TransCelerate, or PhUSE work groups) or via opportunities for review and comment. Participate in regional forums. Share knowledge with colleagues.

Qualifications

  • Bachelor’s degree with 8+ or Master’s degree with 6+ years relevant experience programming and analyzing scientific data in a pharmaceutical/clinical trial environment. University/college degree in a scientific discipline is preferred.

  • In-depth knowledge of the principles and practices of clinical research analysis and reporting is required. Proficiency in SAS programming is required.

  • Expert knowledge of relevant industry standards (eg, ADaM, SDTM) and regulatory requirements (eg, GCP, ICH) related to reporting and data submission is required.

  • Working knowledge of medical concepts sufficient to support a broad range of disciplines is required. Experience in a range of therapeutic areas is preferred.

  • Excellent English written, oral, and interpersonal communication skills are required. Experience acting as a change agent or trainer is preferred.

  • Leadership experience working in a cross-functional team environment with strong collaboration, facilitation, and problem-solving skills is required. Must be able to manage diverse viewpoints and drive issues to resolution.

Primary Location

Belgium-Antwerp-Beerse

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

Clinical Data Management

Requisition ID

1700187576W