Statistical Programming Manager - Janssen Pharmaceuticals - Beerse
Johnson & Johnson Family of Companies
Région
Beerse
Janssen R&D discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases & vaccines, cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
What matters most at J&J 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. We thrive on a diverse company culture, celebrating the uniqueness of our employees and a commitment to inclusion. We are proud to be an equal opportunity employer.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Role Summary:
As a member of the Janssen Integrated Data Analysis and Reporting (IDAR), Statistical Programming and Analysis group, the Statistical Programming Manager plays a key role as a Programming Lead. You will apply project and team leadership capabilities to plan, coordinate and oversee statistical programming team activities, which include the development, verification and documentation of specifications and deliverables in support of clinical trial reporting and regulatory submissions.
You will apply technical expertise and problem-solving skills to complete programming activities of high complexity across 1 or more projects.
In addition to supporting the clinical portfolio you may contribute advanced knowledge and technical skills to departmental innovation and process improvement projects.
Key Responsibilities:
- Coordinate and oversee programming team activities and provides technical and project specific guidance to programming team members to ensure quality and on-time statistical programming deliverables in compliance with departmental processes and procedures.
- Develop detailed programming strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead of programming activities supporting a clinical program, compound or submission.
- Perform comprehensive review of, and provides input into, project requirements and documentation.
- Collaborate effectively within statistical programming and with cross-functional team members, including internal and external members to achieve project goals.
- Ensure continued compliance with required company and departmental training, time-reporting and other business/operational processes as required for position.
- Design and develop programs in support of complex clinical analysis and reporting activities.
- Apply technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality.
- May contribute to or lead others in an area of expertise that results in solutions increasing the efficiency and quality of deliverables across multiple projects.
- May play the role of a Therapeutic/Disease Area Expert providing technical leadership and expertise for a specific therapeutic/disease.
- May contribute to departmental innovation and process improvement projects.
Qualifications
Education:
- Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, or other relevant scientific field (or equivalent theoretical/technical depth) is required.
Experience and Skills:
Required:
- Minimum of 6 years programming experience with increasing responsibility, preferably in a pharmaceutical/clinical trial environment
- Advanced knowledge of relevant statistical programming languages including SAS (required), other relevant programming languages (e.g. R, Python etc. preferred), and data structures
- Demonstrated experience planning and coordinating programming activities and leading programming teams
- Demonstrated working with cross functional stakeholders and teams.
- Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts
- Basic project management skills
Preferred:
- Experience working in the Oncology Therapeutic Area
- Experience working with external vendors/CROs.
Other:
- Excellent written and verbal communication skills in English
- Inter-office travel within country/region (approx. 10%)
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.
Primary Location
United States-Pennsylvania-Spring House-
Other Locations
United States-California-La Jolla, United States-New Jersey-Raritan, United States-California-Los Angeles, United States-New Jersey-Titusville, Belgium-Antwerp-Beerse, United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
9484200731