Job Description

SummaryThe Senior 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. This position supports statistical aspects of business-critical and/or regulatory commitments. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.Core Responsibilities and AccountabilitiesDiscovery and Translational:

• Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers.
• Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed.
• Manages multiple projects.
• Documents projects in sufficient detail for reproducibility.

Medical Affairs:

• Provides statistical support to Medical Affairs studies and assumes responsibilities for planning, design and analysis of randomized clinical trials, observational studies and/or patient registries for post marketing commitments/requirements and reporting related activities.
• Applies sound statistical thinking and computational abilities in support of Medical Affairs goals & objectives.
• Contributes in the planning, design, conduct and analysis for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support; Develops statistical analysis plans (SAPs) and data presentation specifications (DPSs); Provides statistical support for all LCM/regulatory-submission related activities; Interacts with other Medical Affairs functional groups (e.g., HECOR/Epidemiology, Market Access and publication teams); in close partnership with statistical lead, interacts with outside investigators (KOLs and vendors) in the preparation of scientific presentations and manuscripts and pursues implementation of robust statistical analyses in support of business-critical evidence generation; Explores and implements innovative statistical methods.

Post Market Surveillance (PMS)

• Provide advanced statistical expertise in PMS programs, study design, data analysis and interpretation of results for PMS studies. Assume independent, professional responsibilities for analysis operations.
• Lead study design, analysis planning and for 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. Interacts with outside investigators (Key Opinion Leaders (KOLs) and vendors) in the preparation of scientific presentations and manuscripts.
• Implement state0of0the0art statistical approach and technology.
• 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.

Drug Development:

• Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution. 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.
• Provides critical input to 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.
• Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings.
• Contributes positively to SDS team dynamics with a clear understanding of the SDS vision.

External Engagement:

• Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.

QualificationsQualifications

• Ph.D. in Statistics or related field with minimum 0-2 years relevant experience, or Masters in Statistics or related field with commensurate years of relevant experience.

Core CompetenciesProgramming:

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

Process:

• Deep knowledge of data architecture, such as Data Standards. Recognizes the need and value of process standardization.

Expertise:

• Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives.
• Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.
• 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 guidance.
• 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.

Communications:

• Good written, oral, and interpersonal communication skills.

Johnson & Johnson