Clinical Programmer Lead, Clinical Programming

Johnson Johnson are currently seeking a Clinical Programming Lead, Clinical Programming to join our Integrated Data Analytics Reporting (IDAR) Department. This position is based in High Wycombe (Hybrid). Remote work options in the UK may be considered on a case-by-case basis and if approved by 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/.

Position Summary

The Clinical Programming Lead is an experienced clinical trial programmer with expertise in industry standard and complex data structures, programming languages, and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures.

The position is responsible for providing expertise, planning, creation and oversight of one or more clinical programming trial activities of moderate to high complexity/criticality. Including data models for fit for purpose reporting consumption and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, cross and study specific reporting solutions to aid in monitoring of safety, risk, compliance and ensures quality data review.

Responsible for creating efficiencies in the clinical data flow using metadata driven approaches and ensuring the highest level of consistency and quality across trials they support.

Role and responsibilities

• Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality.

• Performs comprehensive review of, and provides input into, project requirements and documentation. Identifies gaps, proposes solutions and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Provides technical and project specific guidance to team members to ensure high quality and on-time deliverables in compliance with departmental processes.

• Ensures latest standards are being utilized, current technologies are deployed.

• Responsible for planning, coordination, oversight and execution of team activities as appropriate and provides technical and project specific guidance to team members to ensure quality and ontime deliverables in compliance with departmental processes and procedures.

• Create and/or review specifications for mapping internal data review model for fit for purpose reporting consumption and/or submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions.

• Responsible for creation or review of internal data model fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions and keeping abreast in changing regulatory requirements. Program, or oversight of quality review checks, cross and study specific reports for use by team members and consumers of data.

Clinical Programmer Lead, Clinical Programming

Johnson Johnson are currently seeking a Clinical Programming Lead, Clinical Programming to join our Integrated Data Analytics Reporting (IDAR) Department. This position is based in High Wycombe (Hybrid). Remote work options in the UK may be considered on a case-by-case basis and if approved by 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/.

Position Summary

The Clinical Programming Lead is an experienced clinical trial programmer with expertise in industry standard and complex data structures, programming languages, and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures.

The position is responsible for providing expertise, planning, creation and oversight of one or more clinical programming trial activities of moderate to high complexity/criticality. Including data models for fit for purpose reporting consumption and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, cross and study specific reporting solutions to aid in monitoring of safety, risk, compliance and ensures quality data review.

Responsible for creating efficiencies in the clinical data flow using metadata driven approaches and ensuring the highest level of consistency and quality across trials they support.

Role and responsibilities

• Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality.

• Performs comprehensive review of, and provides input into, project requirements and documentation. Identifies gaps, proposes solutions and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Provides technical and project specific guidance to team members to ensure high quality and on-time deliverables in compliance with departmental processes.

• Ensures latest standards are being utilized, current technologies are deployed.

• Responsible for planning, coordination, oversight and execution of team activities as appropriate and provides technical and project specific guidance to team members to ensure quality and ontime deliverables in compliance with departmental processes and procedures.

• Create and/or review specifications for mapping internal data review model for fit for purpose reporting consumption and/or submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions.

• Responsible for creation or review of internal data model fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions and keeping abreast in changing regulatory requirements. Program, or oversight of quality review checks, cross and study specific reports for use by team members and consumers of data.

Requirements

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

• Approximately 6-8 years of clinical programming/clinical data management experience with increasing responsibility, preferably in the pharmaceutical/clinical trial environment.

• In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.

• Advanced CDISC SDTM knowledge.

• Experience in planning and coordinating one or more team activities as necessary.

• Demonstrated written and verbal communications skills.

• Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical RD concepts.

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.

Requirements

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

• Approximately 6-8 years of clinical programming/clinical data management experience with increasing responsibility, preferably in the pharmaceutical/clinical trial environment.

• In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.

• Advanced CDISC SDTM knowledge.

• Experience in planning and coordinating one or more team activities as necessary.

• Demonstrated written and verbal communications skills.

• Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical RD concepts.

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.