Clinical Programming Lead
il y a 4 semaines
Within our Clinical & Statistical Programming (C&SP) organization we are looking for experienced individuals with in-depth programming and visualization competencies to join our Clinical Data Analytics & Reporting (CDA&R) team. This is an exciting opportunity to be part of an innovative group that is pivotal in defining our next generation data and visualization strategies.
The Clinical Data Analytics & Reporting Lead, within the CDA&R team, will be responsible for interpretation and translation of clinical data review needs into technical specifications, aggregation of data sources and reporting solutions/visualizations. You will also be responsible for designing and developing technical solutions in support of complex/critical clinical programming, reporting activities, visualization builds and urgent requests. Lastly, you will serve as a delivery contact for stakeholders that could include, but not limited to, risk based central monitoring, data management, clinical scientists/data reviewers, etc.
As required, lead large scale cross-functional projects which require project and stakeholder management skills. Create/develop and improve clinical data safety review and cleaning efficiency by providing innovative and forward-thinking reporting/visualization prototype solutions, report library templates, visualization templates, macros, and other solutions for use cross studies. Provide operational oversight and technical project management of programming and technical activities across multiple trials for assigned areas ensuring effective partnership with key stakeholders as appropriate.
**Responsibilities Include**:
Responsible for planning, coordination, oversight, and execution of team activities as appropriate and provides technical and project specific guidance to team members.
Partner with business representatives to translate requirements for clinical data and reporting/visualization solutions.
Hands-on programming and data manipulation for all aspects of data quality and clinical safety review reports/visuals & dashboards.
Design and develop technical solutions in support of complex/critical clinical programming and reporting/visualization activities, including urgent requests at trial or cross-trial levels.
Serve as primary report/visualization delivery contact for stakeholders.
Provide operational oversight and project management of programming activities across multiple trials for assigned portfolio ensuring effective partnership with key stakeholders as appropriate.
Lead, organize and proactively engage in project team meetings and develop detailed plans as applicable.
Serve as a departmental resource in areas of technical, scientific, disease or therapeutic area expertise.
Contribute to and/or lead departmental innovation and process improvement projects.
Train, mentor, and coach, and may delegate work.
**Qualifications**:
- Bachelor’s degree in Computer, Data or Life Sciences or equivalent work experience is required; Master’s degree preferred.
- 6+ years of relevant experience in pharmaceutical industry is desired, experience in other industries in Programming role will also be considered.
- In-depth knowledge of protocol, current clinical drug development processes preferred.
- In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. SAS, R, Python, or equivalent programming languages is strongly preferred.
- Strong knowledge of complex finding data types, including but not limited to biomarker, digital data such as ECG, imaging, etc. a plus.
- Experience utilizing tools intended for report writing, analytics, visualizations, or dashboard creation (i.e., Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI, or Crystal Reports) is strongly preferred.
- Demonstrated understanding of CDISC requirements and implementation guidelines is preferred, able to consume and translate CDISC standard datasets or similar.
- Experience in planning and coordinating one or more team activities is preferred.
- Project management skills and knowledge of team management principles are required.
- Demonstrated written and verbal communication skills are required.
- Aptitude and motivation to learn modern technologies and make appropriate recommendations for consideration is preferred.
- Vendor management oversight experience is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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