Senior I Statistical Programming Lead - 2406188602W

Description

Johnson & Johnson is currently seeking a Senior I Statistical Programming Lead to join us in High Wycombe

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

DE&I Statement

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Sr I Statistical Programming Lead is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting 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 low-medium complexity/criticality.

The Sr I Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to programming teams.

As an experienced Statistical Programmer this position requires the application of advanced technical and problem-solving skills to complete programming activities of high complexity that may benefit multiple project teams.

In addition, the Sr I Statistical Programming Lead may contribute advanced knowledge and technical skills to Therapeutic Area or departmental innovation and process improvement projects.

Key Responsibilities:

As a Sr I Statistical Programming Lead;

• Accountable for Statistical Programming team delivery for one or more clinical projects generally of low to medium complexity, scope or criticality.

• Coordinates and is responsible for 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.

• Develops 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.

• 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.

• 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 an experienced Statistical Programmer;

• Designs and develops programs in support of complex clinical data analysis and reporting activities.

• Applies 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 contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams.

• Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.

• May contribute to departmental innovation and process improvement projects.

Principal Relationships:

• Reports into people manager position within the functional area. Accountable to the Statistical Programming Portfolio Lead for assigned programming activities and responsibilities.

• Functional contacts include but are not limited to, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within the function, Data Management, Regulatory Medical Writing.

• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Clinical Trial Lead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical – Primary interfaces within clinical project (trial), program, and submission teams.

• External contacts include but are not limited to external partners including CROs.

Qualifications

Qualifications

Education:

• Bachelor’s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth).

Experience and Skills:

Required:

• Approximately 6-8 years relevant programming experience with increasing responsibility, preferably in a pharmaceutical or Clinical R&D environment is required.

• Advanced knowledge of relevant statistical programming languages including SAS is required.

• Experience with other relevant programming languages (e.g. R, Python etc.), and data structures are preferred.

• Demonstrated experience planning and coordinating programming activities and leading teams is required.

• Demonstrated experience working with cross functional stakeholder and teams is required.

• Solid understanding of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

• Basic project management skills.

• Demonstrated written and verbal communication skills.

• Experience working in a team and highly collaborative environment is required.

Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Organization Janssen Cilag Ltd. (7360)

Job Function Biostatistics

Req ID: 2406188602W