Principal Statistical Programming Lead
Johnson & Johnson
Basel, Switzerland
vor 4 Tg.

Job Description

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.

    In this role, you would be responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams.

    As a highly experienced member of the Statistical Programming and Analysis team, you apply expert scientific, technical and problem-solving skills to ensure the operational effectiveness and efficiency of statistical programming activities across assigned projects and provide training or coaching to statistical programmers.

    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

    Education and Experience Requirements :

  • 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 and 5+ yrs relevant experience.
  • Experience in a pharmaceutical / clinical trial environment preferred.

  • Authoritative 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, detailed understanding of end to end clinical trial process and relevant clinical research concepts.
  • Advance knowledge of relevant regulatory guidelines ICH-GCP, 21 CFR Part 11)
  • Demonstrated experience planning and coordinating complex programming strategy and support multiple high complexity tasks.
  • Demonstrated experience leading programming teams to meet project timelines and goals.
  • Basic project management skills.
  • Demonstrated strong written, verbal communication skills with the ability to manage conflicting demands and priorities and negotiate successfully.
  • Proven track record of forging tight-knit collaborations with stakeholder and partner functions.
  • Proven ability to translate complex problems into clear and concise programming code / tools.
  • Preferred Experience

  • Experience managing and overseeing the outsourcing or externalization of statistical programming work in the clinical trials setting Working with CROs, academic institutions).
  • Who We Are!

    Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

    Our commitment to respect the dignity and diversity of all is embedded in our Credo.

    We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

    That is why we are proctively working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feel that they belong and can reach their potential.

    No matter who they are.

    Diversity, Equity & Inclusion at Johnson & Johnson means You Belong !

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