[Innovative Medicine] R&D, Senior Programing Lead, Clinical & Statistical Programming Japan

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 23 hours ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 PostMarketing 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 highquality 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 endtoend PMS programming projects - defining scope and timelines coordinating resources providing handson 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:

Bachelors 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 Japans employee you are not able to apply for multiple positions at once.
For Employee Referral Program (ERP) please read and understand the details of theInternal 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

Required Experience:

Senior IC

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 PostMarketing 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 highquality 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 endtoend PMS programming projects - defining scope and timelines coordinating resources providing handson 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:

Bachelors 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 Japans employee you are not able to apply for multiple positions at once.
For Employee Referral Program (ERP) please read and understand the details of theInternal Referral Overview on the Ask GS and you have made a compliant referral.

Required Skills:

Preferred Skills:

Required Experience:

Senior IC

Key Skills

Laboratory Experience
Vendor Management
Design Controls
C/C++
FDA Regulations
Intellectual Property Law
ISO 13485
Research Experience
SolidWorks
Research & Development
Internet Of Things
Product Development

Apply Now

About Company

Johnson & Johnson

About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click

AI Resume Builder

Create an ATS-ready CV in minutes

AI Cover Letter

Write a personalized letter instantly

[Innovative Medicine] R&D, Senior Programing Lead, Clinical & Statistical Programming Japan

Tokyo - Japan

Job Summary

Position Summary:

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:

Bachelors 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.

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

Position Summary:

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:

Bachelors 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.

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

Key Skills

About Company

Related Jobs