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About the Role

The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. This role requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams. The position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality.

Responsibilities

Designs and develops efficient programs and technical solutions for complex/critical clinical research analysis and reporting.
Provides technical and project-specific guidance to programming team members.
Coordinates and oversees programming team activities, potentially providing matrix leadership.
Performs comprehensive review of and provides input into project requirements and documentation.
Collaborates effectively with programming and cross-functional team members.
Oversees programming activities outsourced to third-party vendors.
Responsible for adoption of new processes & technology on assigned projects/programs.
Contributes to and may lead departmental innovation and process improvement projects.
Ensures continued compliance of projects/programs and required company/departmental training.
Oversees the design, development, validation, management, and maintenance of clinical databases.
Responsible for implementation of data tabulation standards.
Performs data cleaning by programming edit checks and data review listings.
Provides data reporting by creating data visualizations and listings for medical monitoring and central monitoring.
Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design.

Requirements

Bachelor's degree (e.g., BS, BA) or equivalent professional experience, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field.
Approx. 6+ years of experience in Pharmaceutical, CRO or Biotech industry or related field.
In-depth knowledge of programming practices (including tools and processes).
Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11).
Project, risk, and team management experience.
Established track record leading teams to successful outcomes.
Excellent planning and coordination of project delivery.
Established track record collaborating with multi-functional teams in a matrix environment.
Demonstrated ability to foster team productivity and cohesiveness.
Expert CDISC Standards knowledge.
Expert knowledge of relevant programming languages for data manipulation and reporting (SAS knowledge is required).
Excellent written and verbal communications, influencing and negotiation skills.
Advanced knowledge of programming and industry standard data structures.
Thorough understanding of end-to-end clinical trial process and relevant clinical research concepts.

Skills

Advanced Analytics
Biostatistics
Clinical Data Management
Collaboration
Compliance Management
Critical Thinking
Data Privacy Standards
Good Clinical Practice (GCP)
Organizing
Presentation Design
Program Management
Quality Assurance (QA)
Regulatory Affairs Management
Research Documents
Standard Operating Procedure (SOP)
Statistical Analysis Systems (SAS) Programming
Survey Design
SAS
R
Python

Location

Chiyoda, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan

Work Type

Full-time

Experience Level

Principal
6+ years

Education Level

Bachelor's degree
Master's degree
PhD

About the Company

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/.

Equal Opportunity

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.