Manager, Standards Management (DAS/TFL)

We are searching for the best talent for a Manager, Standards Management Expert (DAS/TFL) within Integrated Data Analytics & Reporting (IDAR), to provide expert guidance and tailored solutions on projects, programs, and processes that span multiple related areas in support of the organization's overall Clinical Data Standards strategy. The Standards Management Expert (DAS/TFL) is an individual contributor who takes a leadership role in the collaboration with various internal and external partners to ensure consistency of clinical data standards across clinical trials and in compliance with regulatory requirements., * 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 agreed 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.

You will be responsible for:

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:

• 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 is responsible for acquiring and maintaining deep expertise in the various data collection and analysis tools and templates applied in the clinical trials, specifically those in use in J&J (e.g., AUTOCODE), in industry standards, including but not limited to CDISC standards and adjacent data standards (e.g., HL7 / FHIR, OHDSI/OMOP).

The role should be knowledgeable in using common clinical data tools such as LSAF, Pinnacle 21, or SAS. The position may also be involved in innovative projects which requires learning of new tools and standards.

The role is responsible for remaining aware of the industry standards development and trends, and regulatory requirements, to support the development strategy and evolution of the J&J.

The role may also have responsibility for providing operational expertise in cross functional initiatives.

• 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 relevant 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 business 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.

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. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
• Subject to the terms of their respective plans, employees are eligible to 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. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation -120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
• Holiday pay, including Floating Holidays -13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year, Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Innovation, Leverages Information, Process Improvements, Regulatory Affairs Management, Research Ethics, Technical Credibility The anticipated base pay range for this position is : $117,000.00 - $201,250.00 Additional Description for Pay Transparency

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 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.