Principal Statistical Programming Lead

**Principal Statistical Programming Lead**:
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a **Principal Statistical Programming Lead** within Janssen Research & Development (JRD), to be located in **High Wycombe UK, or Leiden, Netherlands; Beerse, Belgium; Basel, Switzerland; France or Germany.**

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are proactively working to create a world without disease. Redefining lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

The **Principal Statistical Programming Lead** is a highly qualified Statistical Programmer with commanding knowledge of Statistical Programming languages, tools and data structures, confirmed technical and analytic abilities and strong capabilities in leading Statistical Programming activities and programming teams in accordance to departmental processes and procedures. This position is accountable for the planning, oversight and delivery of statistical programming activities supporting one or more clinical projects, compounds and/or submissions generally of high complexity/criticality. In addition, this position leads and/or contributes expert knowledge and technical skills to Therapeutic area and/or departmental innovation and process improvement projects.

**Principal Responsibilities**:

- Accountable for Statistical Programming team delivery for 1 or more highly complex clinical projects in terms of scope and/or criticality.
- Provides matrix leadership to 1 or more programming teams, coordinating and leading all aspects of programming team activities. May act as a section lead of programming activities supporting a clinical development program, compound or submission.
- Positively contributes to and applies strategic development and maintenance of detailed programming strategy and plans.
- Provides technical and project specific guidance to programming team members to ensure high quality and timely deliverables in compliance with departmental processes.
- Performs comprehensive review of, and provides input into, project requirements and documentation.
- Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals.
- Independently manages interfaces and escalations with cross-functional project teams.
- As applicable, supervises statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.
- Designs and develops programs and technical solutions in support of highly sophisticated/critical clinical research analysis and reporting activities, including urgent/on-demand analysis request.
- Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality.
- Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental Technical groups and programming portfolio leads.
- Shares knowledge, guides and coaches’ statistical programmers in developing advanced technical and analytical abilities.
- Serves as a departmental resource in areas of scientific, technical and/or therapeutic/disease area expertise.
- Contributes to and may lead Therapeutic Area and/or departmental innovation and process improvement projects and may contribute functional statistical programming expertise to cross-functional projects/initiatives.
- Ensures continued compliance with required company and departmental training, time-reporting, and other business/operational processes as required for position.
- May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams.

**Principal Relationships**:

- Reports into people manager position within the Statistical Programming functional area. Accountable to the Statistical Programming TA Head and/or Statistical Programming Portfolio Lead for assigned programming activities and responsibilities.
- Functional contacts within IDAR may include but are not limited to Statistical Programming TA Head, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within department, IDAR Therapeutic Area Lead, Data Management and Clinical Data Standards, Regulatory Medical Writing.
- Functional contacts within Janssen (as collaborator or peer) include but are not limited to Trial Lead or equivalent, Quantitative Sciences, Biostatisticians, Regulatory, Clinical.
- External contacts include, external partners, CRO management and vendor liaisons, industry peers and working groups.

**Qualifications**