Principal Scientist, Model-Based Meta-Analysis - Johnson and Johnson

Johnson & Johnson is currently seeking a Principal Scientist, Model-Based Meta-Analysis (MBMA). This position can be located in San Diego, CA; Titusville, NJ; Raritan, NJ; or Spring House, PA. Additional Johnson & Johnson Innovative Medicine sites within the United States may be considered.

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

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.

The Quantitative Sciences and Clinical Pharmacology (QSCP) group at Janssen uses mathematical modeling techniques to integrate data from various sources to facilitate model-informed decisions for drug development. The Model-Based Meta-Analysis (MBMA) group provides the quantitative expertise in building integrative models from published clinical trials to facilitate benchmarking, Go/No-go decisions and staged clinical trial design. The group works with clinical development teams across various therapeutic areas to find opportunities to apply such integrative models in informed decision making. This individual will report to the Head of the MBMA group.

Principal Responsibilities:

• Develop MBMA models based on internal and external aggregate-level data.
• Support clinical development teams through utilization of MBMA models to improve clinical trial design and decision making.
• Effectively communicate results through presentations and summarize methods and results through reports and other documents.
• Work collaboratively across various functions to support the identification of new opportunities for data-informed decision making at program and portfolio levels. Additionally, support initiatives to collaborate with other quantitative groups to create value in the Janssen pipeline and contribute to Janssen as a leader in model-informed drug discovery and development.
• External collaborations, visibility, and impact: support in engaging in external collaborations within professional associations (e.g., International Society of Pharmacovigilance (ISoP)), presenting at scientific meetings, and publishing in peer reviewed journals to influence the external pharmaceutical industry and regulatory environment.
• Carry out functional responsibilities in accordance with applicable SOPs/Guidelines and Regulatory requirements.
• Assist in process improvement initiatives and SOP/Guideline development.
• Work closely with Clinical Development Leads (CDLs) and other Clinical Development Team (CDT) members as well as members within Clinical Pharmacology and Pharmacometrics and Statistical and Decision Sciences. Will also work with external vendors as needed.

• A minimum of a Master's degree in Statistics, Engineering or a related discipline is required. PhD or equivalent degree in Bioengineering, Biostatistics, Data Science or a related discipline is preferred.
• A minimum of 6 years of relevant work experience in drug development and applied quantitative methods with a Master's degree or a minimum of 3 years of relevant work experience in drug development and applied quantitative methods with a PhD or equivalent degree is required.
• Familiarity with scientific programming and simulation is required.
• Working knowledge of modeling software, such as R, is required.
• Deep understanding of various mathematical modeling techniques, specifically with a focus on applications in drug discovery and development, is required.
• Experience with Bayesian applications is preferred.
• Experience and knowledge of Good Clinical Practices (GCPs) and regulatory requirements for clinical drug development, including the conduct of clinical trials, is preferred.
• Must have strong communication and presentation skills, including fluency in English (writing and verbal).
• Must have a good sense of cultural sensitivity and diversity.
• The ability to build and maintain effective working relationships in a cross-functional team environment is required.
• The ability to collaborate with cross-functional groups (e.g., biostatistics, clinical pharmacology, clinical, etc.) is required.
• Up to 10% travel is required.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $139,000 to $224,825.

The anticipated base pay range for this position in all other U.S. locations is $113,000 to $195,500.

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.

This job posting is anticipated to close on October 7, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.