Data Analysis Standards Director

Description

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

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Data Analysis Standards Director

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. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for a Data Analysis Standards Director in our Clinical Data Standards (CDS) team to guide and support direct reports in the delivery of the CDS goals and objectives, providing meaningful input for their career development. As a member of the CDS leadership team, the position provides expertise and input for the development of the CDS strategy and oversight. The position may be located: High Wycombe, United Kingdom; Beerse, Belgium; Breda, Netherlands; Allschwil, Switzerland, or Raritan/Spring House/Titusville, United States. Hybrid preferred (3 days onsite weekly). Remote options will be considered on a case by case basis and with approval from the company.

The Data Analysis Standards Director is responsible for overseeing the definition and execution of the CDS vision and strategy to enable J&J clinical trials with fit-for-purpose standards primarily focusing on analysis standards for use in clinical trials, including but not limited to assessments and statistical endpoints, statistical methods, ADaM metadata, and displays used in the clinical report. The position is responsible for ensuring that standards are structured and governed in a manner that is well-aligned with stakeholder processes in order to maximize efficiencies and value. The position is responsible for operational fit and ensuring that these standards have incorporated the best available medical knowledge and comply with relevant regulatory requirements and industry standards. The position operates in a matrix environment, collaborating with cross functional leaders in IDAR (Integrated Data Analytics & Reporting), GD (Global Development) and other functions.

Are you ready to join our team? Then please read further!

You will be responsible for:

• Directing managers and/or senior individual contributors in a matrix environment and accountable for meaningful career development conversations and regular coaching and feedback.
• Managing operational aspects of your team (e.g., budget, performance, and compliance), and implementing workforce and succession plans to meet business needs.
• Proactively creating a purpose driven environment by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.
• Providing expertise in company programs and initiatives, delivering Clinical Data Standards input.
• Influencing the implementation of innovative methods in the implementation of clinical data standards, ensuring integrity throughout the data lifecycle, as well as compliance with regulatory health authority requirements.
• Driving alternative solutions to address data standards, business, and operational challenges.
• Overseeing the CDS stakeholder management and provides direction for the CDS communication strategy to increase visibility to the organization.

Principal Relationships: Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Clinical Data Standards and others as needed. External: Interact and collaborate with vendors. Act as J&J representative for defining process standards and sharing practices with industry counterparts and working groups, as required.

Qualifications /Requirements:

• Advanced degree in a scientific, technology or healthcare discipline, or equivalent experience
• At least 10 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)
• Proven experience in initiating and leading cross-functional projects
• Excellent written and verbal communications skills
• Demonstrated leadership in decision making and problem solving
• Demonstrated customer focus and solution-oriented experience
• Excellent interpersonal skills to build relationships with internal and external business partners
• Proven people leadership skills in a global environment Other:
• Excellent spoken and written English

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-019326

Netherlands, Switzerland- Requisition Number: R-020571

United States - Requisition Number: R-020574

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

For United States applicants:

The anticipated base pay range for this position is $160,000 to $276,000.

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.

Employees and/or eligible dependents may be 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.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

- Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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