[Janssen] Statistician, PMS

Position Summary

The Statistician provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in Janssen. Activities associated with the role will require guidance from managers and project statisticians. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.

Position Core Competencies, Responsibilities and Accountabilities

・Expertise: Demonstrates data analytic expertise based on a foundation of statistical principles. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues. Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.

・Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting.  Understands and aligns with relevant regulatory guidances. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.

・Drug Development: Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support. Is accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects. Supports the statistical lead or team in optimizing study or trial designs in line with study or trial objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.

・Collaboration: Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management. Contributes to area (e.g. discovery, translational, early development, late development) project meetings when required. Contributes positively to SDS team dynamics.

Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.

・External Engagement: Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.

Process: Basic knowledge of data architecture and formats, such as Data Standards.

Area Specific Core Competencies, Responsibilities and Accountabilities

These are additional to the above position core competencies, applicable to individuals according to their assigned area within Statistics & Decision Sciences.

Post Marketing Surveillance(PMS)

Provide statistical expertise in PMS programs, study design, data analysis and interpretation of results for PMS studies.  Assume responsibilities for analysis operations.

Contribute to the development of statistical analysis plan (SAP) and data presentation plan (DPS) for PMS studies.  Monitor the analysis operations conducted by vendors, an oversees design and implement quality control measures to ensure the quality and integrity of statistical results.

Provide consultancy for statistical questions from medical affairs/business units or external customers.  In close partnership with the senior statistical leader, contribute to data generation requests from external investigators (Key Opinion Leaders (KOLs) and vendors) in the preparation of scientific presentations and manuscripts.

Implement “state‐of‐the‐art” statistical approach and technology as much as possible.

Contribute to the implementation of continuous process improvements while maintain sustainable efficiency in globally consistent processes, such as data standards and process standardization.

Basic knowledge of project management.

Interfaces

・Internal: Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance.

・External: Contracted Partners, Academia, Professional Societies.