Janssen Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Principal Analyst (Senior Manager) to be in Titusville, NJ, Raritan, NJ or Spring House, PA. Consideration may be given to working remote for the right individual.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Principal Analyst (Senior Manager) within IDAR is an individual contributor and an experienced member of the Statistical Programming and Analysis functional area with proven technical/analytical abilities and expertise in each therapeutic area.
This position may combine the roles of a Programming Team Leader (Programming/Project Lead) who plans and provides oversight of statistical programming activities (e.g., development, verification and documentation) in support of clinical trial reporting and submissions of high complexity/criticality; and/or that of a technical/scientific leader who develops technical solutions and or disease area/therapeutic area standards resulting in operational effectiveness and efficiencies.
The Principal Analyst (Senior Manager) is expected to have a high level of intra/inter project impact within a TA and is someone who can operate independently requiring minimal guidance.
Essential Responsibilities include:
As Trial/Project Programming Leader:
As Scientific/Technical Leader:
- Coordinates and oversees programming team activities and provides technical and project specific guidance to programming team members to ensure quality and on-time deliverables in compliance with departmental processes. Including outsourced tasks to third party vendors and ensures their performance meets the agreed upon timelines, quality and budget established for the project or study.
- Performs comprehensive review of, and provides input into, project requirements and/or project documentation.
- Applies strategic decisions and recommendations to develop detailed programming strategy and plans the programming deliverables for projects of high complexity and/or scope.
- Designs and develops programs in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis.
- Collaborates effectively within statistical programming and with cross-functional working group team members and functional counterparts, including internal and external members.
As an Experienced member of the functional area:
- Contributes to the standards strategy for the TA. Accountable for developing disease area standards/owning the content of data life cycle plan (DLP).
- Accountable for actively identifying opportunities, evaluating and driving solutions to enhance efficiency. Applies technical and analytical expertise to develop and implement solutions for use on multiple projects, leading to increased efficiency and quality across programming teams.
- Partners with key stakeholders (e.g. eBIS group and Clinical Data Standards (CDS) and Analytics Innovation Team (AIT), industry forums to help drive programming efficiency.
- Provide technical advice to teams and may work with other disciplines outside department to solve complex problems.
- Shares knowledge and guides programmers in developing technical and analytical abilities.
- Serves as a departmental resource in areas of technical expertise.
- May participate in cross-IDAR or cross-functional initiatives/process improvements.
- A Bachelor’s degree, preferably in a scientific discipline, with 6+ years relevant experience OR Master’s/MBA with 4 years relevant experience; OR PhD with post-doc experience with 3 years relevant experience is required.
- In-depth knowledge of statistical programming and industry standard data structures, and thorough understanding of end-to-end clinical trial process and relevant clinical research concepts is required.
- Working knowledge of regulatory guidelines and publishing processes (e.g. 21 CFR Part 11), basic project management techniques/skills, and team leadership skills is required.
- Ability to manage conflicting demands and priorities and to negotiate successfully is required.
- Proven ability to forge strong collaborations with partner functions to have program (e.g. Disease Area/Therapeutic Area level) and/or department level impact is required.
- Demonstrated intellectual curiosity and innovative thinking to shape solutions to allow for optimal design strategies and execution is required.
- Recognized expertise in SAS programming and SAS macro code development is required.
- Understanding of other SAS products (e.g. SAS/GRAPH, SAS Output Delivery System, etc.) is preferred.
- Proven ability to translate a complex problem into clear and concise SAS code is required.
- Previous experience and expert in dealing with adhoc requests is required.
- Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions) is required.
- Knowledge of non-SAS programming packages/languages (e.g. Spotfire, S-Plus, R) is preferred.
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)