Principal Statistical Programming Lead

vor 18 Stunden

Allschwil, Schweiz Johnson & Johnson Vollzeit

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

**Principal Statistical Programming Lead**

Location: Allschwil, Basel

Position: Full-time, permanent

The Principal Statistical Programming Lead is a highly experienced Statistical Programmer with expert knowledge of Statistical Programming languages, tools and data structures, proven 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 in support of 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**:

- As a Programming Lead_
- Accountable for Statistical Programming team delivery for 1 or more clinical projects of high complexity, scope and/or criticality.
- Provides matrix leadership to 1 or more programming teams, coordinating and overseeing programming team activities. May act as a section lead of programming activities supporting a clinical development program, compound or submission.
- Contributes to and applies strategic decisions and recommendations, developing and maintaining detailed programming strategy and plans.
- Provides technical and project specific guidance to programming team members to ensure high quality and on-time 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, oversees 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.
- As a highly experienced Statistical Programmer_
- Designs and develops programs and technical solutions in support of highly complex/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 statistical 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.

**Qualifications**
- Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) required. Advanced degree (Master’s, PhD or equivalent) preferred.
- Approximately 8-10+ years programming experience with increasing responsibility OR Masters/MBA in a relevant field and 6-8+ yrs relevant experience OR PhD in a relevant field and 5+ yrs relevant experience. Experience in a pharmaceutical/ clinical trial environment preferred.
- Expert knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred.
- Advanced knowledge of statistical programming and industry standard data structures, thorough understanding of end to end clinical trial process and relevant clinical research concepts.
- Working knowledge of relevant regulatory guidelines (e.g. ICH-GCP, 21 CFR Part 11)
- Demonstrated experience planning and coordinating complex programming strategy and

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