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Job Function:

Data Analytics & Computational Sciences:

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

Position Summary:

The Senior Programming Lead is an experienced programmer with an advanced knowledge of programming languages, has expertise in industry standards, complex data structures and programming methods, having the technical capabilities in leading trial activities in accordance with departmental processes and procedures.

The Senior Programming Lead for Post‑Marketing Surveillance (PMS) drives the standardization of PMS programming processes conducted by external vendors, workflows, dataset specification templates, and data presentation specification (DPS) templates for PMS studies; develops and maintains reusable PMS code/specifications for acceptance confirmation as a sponsor; and delivers high‑quality PMS outputs (e.g., analysis datasets, tables and listings) in partnership with Statistics, Data Management, Post Approval Delivery Unit, and external vendors. The role oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. The role plans and manages end‑to‑end PMS programming projects - defining scope and timelines, coordinating resources, providing hands‑on technical direction, and ensuring adherence to applicable PMS regulations and internal SOPs.

Principal Relationships:

This role reports into a people manager position within the C&SP Japan

PMS-related collaborators include but are not limited to: Statistics, Data Management, Post Approval Delivery Unit and external vendors.

Education and Experience Requirements:

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

Experience and Skills Required:

Approx. 4+ years programming experience with increasing responsibility preferably in PMS environment.

Hands-on experience handling PMS studies, with knowledge of applicable PMS regulations; experience with standardized dataset specification/DPS templates and deliverables (e.g., datasets, tables and listings, relevant documents).

Knowledge of programming practices (including tools and processes).

Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. Knowledge of SAS is required.

Demonstrated written and verbal communication skills in English.

Experience in planning and coordinating programming activities and leading teams.

Experience working with cross functional stakeholders and teams.

Experience in vendor management oversight.

Project management skills and knowledge of team management principles.

Working knowledge of post-marketing regulatory requirements relevant to statistical analysis and reporting

　　Preferred qualifications;

Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

Expert CDISC Standards knowledge.

＜For Internal Applicants＞

Based on your experience and interview evaluation, the position title and level may vary.

If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.

For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on the Ask GS and you have made a compliant referral.

Required Skills:

Preferred Skills:

Advanced Analytics, Biostatistics, Clinical Trials, Collaborating, Consulting, Critical Thinking, Data Privacy Standards, Data Quality, Data Savvy, Digital Fluency, Good Clinical Practice (GCP), Quality Assurance (QA), Report Writing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Statistics, Systems Development, Technologically Savvy