Manager, Standards Management (DAS/TFL)
Johnson & Johnson, Titusville, FL, United States
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.
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.
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Clinical Data Management
Job Category:
Professional
All Job Posting Locations:
Titusville, New Jersey, United States of America
Job Description
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
We are searching for the best talent for a
Manager, Standards Management Expert (DAS/TFL)
within Integrated Data Analytics & Reporting (IDAR). This individual contributor will provide expert guidance and tailored solutions on programs that support the organization's overall Clinical Data Standards strategy. The Standards Management Expert (DAS/TFL) collaborates with internal and external partners to ensure consistency of clinical data standards across trials and compliance with regulatory requirements.
Potential Locations:
High Wycombe, UK; Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland; Titusville, United States; or Mumbai, India (Hybrid: 3 days per week onsite)
Recruitments may be posted under different requisition numbers per country. Apply to your preferred location(s) while focusing on the corresponding requisition number(s).
Purpose
Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization.
Manages standards, projects, programs, or processes for Clinical Data Standards in line with internal strategy and regulatory requirements.
Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams.
Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards.
Coaches and trains junior colleagues in clinical data standards application and responsibilities.
Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.
Responsibilities
Manager, Standards Management Expert (DAS/TFL)
is responsible for the development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, delivery, analysis & reporting, aligned with program requirements and medical writing. Examples of standard content include:
Supportive documentation to guide and support consistent adoption of standards in clinical trials.
Standard text, definitions, and analysis requirements that are included in the Protocol and Statistical Analysis Plan.
Standard tables, listings and graph mock displays along with detailed analysis requirements and standard analysis rules included in the Data Presentation Specifications.
The role requires deep expertise in data collection and analysis tools used in J&J (e.g., AUTOCODE), in industry standards such as CDISC, HL7 / FHIR, OHDSI/OMOP, and similar data standards.
Skills in tools such as LSAF, Pinnacle 21, or SAS are necessary, with a willingness to learn new tools and standards for innovative projects.
Remaining aware of industry standards development and trends, and regulatory requirements, to support J&J’s development strategy and evolution.
The role may also provide operational expertise in cross-functional initiatives.
Qualifications / Requirements
A Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD).
At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming.
Expert knowledge of regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM).
Demonstrated written and verbal communications skills.
Demonstrated customer focus and solution-oriented experience.
Demonstrated interpersonal skills to build relationships with internal and external partners.
Demonstrated leadership on cross-functional projects.
Demonstrated leadership in decision making and problem solving.
Excellent spoken and written English.
Ability to commute to one of the aforementioned office locations.
Benefits
For United States Applicants
The expected pay range for this position is $117,000 to $201,250.
The Company maintains highly competitive, performance-based compensation programs and offers an annual performance bonus based on individual and corporate results.
Employees (and eligible dependents) can participate in medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance programs.
Employees can participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Time off benefits include vacation (120 hours per calendar year), sick time (40 hours per calendar year; 48 hours in Colorado; 56 hours in Washington), holiday pay and floating holidays (13 days per calendar year), work/personal/family time (up to 40 hours per calendar year), parental leave (480 hours within one year of birth/adoption/foster care), bereavement leave (240 hours for immediate family; 40 hours for extended family per calendar year), caregiver leave (80 hours in a 52-week rolling period), volunteer leave (32 hours per calendar year), and military spouse time-off (80 hours per calendar year).
For additional general information on company benefits, visit https://www.careers.jnj.com/employee-benefits.
Pay Transparency
The anticipated base pay range for this position is $117,000.00 - $201,250.00.
This job posting is anticipated to close on April 10th, 2026. The posting may remain available for additional applications if extended.
Johnson & Johnson is an Equal Opportunity Employer. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We are committed to providing an inclusive interview process and accommodations for applicants with disabilities.
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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.
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Clinical Data Management
Job Category:
Professional
All Job Posting Locations:
Titusville, New Jersey, United States of America
Job Description
About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
We are searching for the best talent for a
Manager, Standards Management Expert (DAS/TFL)
within Integrated Data Analytics & Reporting (IDAR). This individual contributor will provide expert guidance and tailored solutions on programs that support the organization's overall Clinical Data Standards strategy. The Standards Management Expert (DAS/TFL) collaborates with internal and external partners to ensure consistency of clinical data standards across trials and compliance with regulatory requirements.
Potential Locations:
High Wycombe, UK; Beerse, Belgium; Leiden, Netherlands; Allschwil, Switzerland; Titusville, United States; or Mumbai, India (Hybrid: 3 days per week onsite)
Recruitments may be posted under different requisition numbers per country. Apply to your preferred location(s) while focusing on the corresponding requisition number(s).
Purpose
Acts as a top-level specialist to establish programs and innovative strategies that advance the Clinical Data Standards organization.
Manages standards, projects, programs, or processes for Clinical Data Standards in line with internal strategy and regulatory requirements.
Participates in the development of solutions to provide accurate, timely, and consistent clinical data standards to study teams.
Communicates ideas for process improvement, while supporting the design and integration of new technologies to enhance clinical data standards.
Coaches and trains junior colleagues in clinical data standards application and responsibilities.
Integrates Johnson & Johnson’s Credo and Leadership Imperatives into team goals and decision making.
Responsibilities
Manager, Standards Management Expert (DAS/TFL)
is responsible for the development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, delivery, analysis & reporting, aligned with program requirements and medical writing. Examples of standard content include:
Supportive documentation to guide and support consistent adoption of standards in clinical trials.
Standard text, definitions, and analysis requirements that are included in the Protocol and Statistical Analysis Plan.
Standard tables, listings and graph mock displays along with detailed analysis requirements and standard analysis rules included in the Data Presentation Specifications.
The role requires deep expertise in data collection and analysis tools used in J&J (e.g., AUTOCODE), in industry standards such as CDISC, HL7 / FHIR, OHDSI/OMOP, and similar data standards.
Skills in tools such as LSAF, Pinnacle 21, or SAS are necessary, with a willingness to learn new tools and standards for innovative projects.
Remaining aware of industry standards development and trends, and regulatory requirements, to support J&J’s development strategy and evolution.
The role may also provide operational expertise in cross-functional initiatives.
Qualifications / Requirements
A Bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience. Advanced degrees preferred (e.g., Master, PhD).
At least 6 years of relevant pharmaceutical/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming.
Expert knowledge of regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM).
Demonstrated written and verbal communications skills.
Demonstrated customer focus and solution-oriented experience.
Demonstrated interpersonal skills to build relationships with internal and external partners.
Demonstrated leadership on cross-functional projects.
Demonstrated leadership in decision making and problem solving.
Excellent spoken and written English.
Ability to commute to one of the aforementioned office locations.
Benefits
For United States Applicants
The expected pay range for this position is $117,000 to $201,250.
The Company maintains highly competitive, performance-based compensation programs and offers an annual performance bonus based on individual and corporate results.
Employees (and eligible dependents) can participate in medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance programs.
Employees can participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Time off benefits include vacation (120 hours per calendar year), sick time (40 hours per calendar year; 48 hours in Colorado; 56 hours in Washington), holiday pay and floating holidays (13 days per calendar year), work/personal/family time (up to 40 hours per calendar year), parental leave (480 hours within one year of birth/adoption/foster care), bereavement leave (240 hours for immediate family; 40 hours for extended family per calendar year), caregiver leave (80 hours in a 52-week rolling period), volunteer leave (32 hours per calendar year), and military spouse time-off (80 hours per calendar year).
For additional general information on company benefits, visit https://www.careers.jnj.com/employee-benefits.
Pay Transparency
The anticipated base pay range for this position is $117,000.00 - $201,250.00.
This job posting is anticipated to close on April 10th, 2026. The posting may remain available for additional applications if extended.
Johnson & Johnson is an Equal Opportunity Employer. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We are committed to providing an inclusive interview process and accommodations for applicants with disabilities.
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