Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
Senior Manager Statistical Programming - Principal Analyst - Project GIFTS
Requisition ID: 1805650971W
Sr. Manager Statistical Programming – Principal Analyst – Janssen
Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Statistical Programmer Analyst.
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. And we pursue the most promising science, wherever it might be found.
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.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
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 a given 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..
Principal responsibilities will include:
As trial/project programming 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 scientific/technical leader -
- 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 diciplines 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
and relevant experience OR Masters/MBA +experience; OR PhD with post-doc
degree in a scientific discipline is preferred.
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. This role requires a working knowledge of regulatory guidelines and publishing processes (e.g. 21 CFR Part 11), basic project management techniques/skills, and team leadership skills.
Demonstrated strong written, verbal communication skills. Ability to manage conflicting demands and priorities and to negotiate successfully. Proven ability to forge strong collaborations with partner functions to have program (e.g. Disease Area/Therapeutic Area level) and/or department level impact.
Demonstrated intellectual curiosity
and innovative thinking to shape solutions to allow for optimal design
strategies and execution. Recognized expertise in SAS programming and
SAS macro code development. Understanding of other SAS products (e.g.
SAS/GRAPH, SAS Output Delivery System, etc.). Proven ability to translate
complex problems into clear and concise SAS code. Ability to support multiple
complex tasks (e.g. adhoc requests).
Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions). Knowledge of non-SAS programming packages/languages (e.g. Spotfire, S-Plus, R).
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)