Principal Scientist, Model-Based Meta-Analysis

2+ years

Not Disclosed

Remote, USA

10 Nov. 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Scientist, Model-Based Meta-Analysis

Function: Discovery & Pre-Clinical/Clinical Development
Sub-function: Pharmacokinetics & Pharmacometrics
Location Options: San Diego, CA; Titusville, NJ; Raritan, NJ; Spring House, PA (Other Johnson & Johnson Innovative Medicine sites in the U.S. may be considered)
Date Posted: November 1, 2024
Requisition Number: 2406213610W

About Johnson & Johnson:

At Johnson & Johnson, we believe health is everything. We harness the power of healthcare innovation to build a world where complex diseases are prevented, treated, and cured, where treatments are more effective, smarter, and less invasive. By combining the expertise of our Innovative Medicine and MedTech divisions, we are positioned to drive the breakthroughs of tomorrow and make a profound impact on global health. Learn more about us at www.jnj.com.

For over 130 years, Diversity, Equity, and Inclusion (DEI) have been the cornerstone of our culture and operations. Rooted in our Credo, these values drive our mission to create a healthier, more equitable world. Our diverse workforce fosters an environment of belonging, where innovation thrives to solve the world’s most pressing healthcare challenges.

Job Purpose and Scope:

We are looking for a Principal Scientist, Model-Based Meta-Analysis (MBMA) to join our Quantitative Sciences and Clinical Pharmacology (QSCP) group at Janssen. This position will focus on building and applying integrative models from published clinical trials to facilitate benchmarking, clinical trial design, and decision-making across multiple therapeutic areas. The ideal candidate will bring their expertise in quantitative modeling to guide critical decisions in drug development.

This position offers the opportunity to work with clinical development teams to leverage MBMA models for optimizing clinical trial design and improving decision-making processes. You will also engage in external collaborations and contribute to scientific presentations and publications to influence the broader pharmaceutical industry and regulatory environment.

Principal Responsibilities:

As the Principal Scientist, Model-Based Meta-Analysis, your responsibilities will include:

Model Development & Analysis:
- Develop MBMA models based on internal and external aggregate data to support key decision-making.
- Collaborate with clinical development teams to optimize clinical trial designs using MBMA models.
Collaborative Leadership:
- Engage cross-functionally to identify and implement opportunities for data-informed decision-making across programs and portfolios.
- Collaborate with other quantitative groups to drive innovation in the Janssen pipeline.
External Visibility & Impact:
- Represent the MBMA group in external collaborations, professional associations (e.g., ISoP), scientific meetings, and publications to shape the external pharmaceutical and regulatory landscape.
Process Improvement:
- Contribute to process improvement initiatives and support the development of SOPs/guidelines in the pharmacometrics and modeling space.
Cross-functional Collaboration:
- Work closely with Clinical Development Leads (CDLs), Clinical Development Teams (CDTs), Clinical Pharmacology, Pharmacometrics, and Statistical/Decision Sciences teams to align on strategy and execution.
- Coordinate with external vendors as needed to meet project objectives.

Qualifications:

Education:

A Master’s degree in Statistics, Engineering, or a related discipline is required. A PhD in Bioengineering, Biostatistics, Data Science, or related fields is preferred.

Experience:

A minimum of 6 years of relevant experience in drug development and applied quantitative methods with a Master’s degree, or 3 years of experience with a PhD or equivalent degree.
Familiarity with scientific programming and simulation is required.
Proficiency in modeling software (such as R) is essential.
Expertise in mathematical modeling techniques, particularly in drug discovery and development, is required.
Experience with Bayesian methods is preferred.
Knowledge of Good Clinical Practices (GCP) and regulatory requirements for clinical trials is preferred.

Skills & Competencies:

Strong communication and presentation skills in English (both written and verbal).
Ability to build and maintain strong working relationships in a cross-functional team environment.
Cultural sensitivity and the ability to work effectively in a diverse team setting.
Up to 10% travel required.

Compensation & Benefits:

Base Pay Range (San Francisco Bay Area): $139,000 - $224,825
Base Pay Range (Other U.S. Locations): $113,000 - $195,500

In addition to competitive salary packages, Johnson & Johnson offers a comprehensive benefits program including:

Medical, dental, and vision insurance
Life and disability insurance
Retirement plans (pension and 401(k))
Vacation (up to 120 hours per year)
Sick time, holiday pay, and other time-off benefits
Wellness and employee development programs

For more information on our employee benefits, visit Johnson & Johnson Careers.

Additional Information:

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

For more information about our company and opportunities, please visit Johnson & Johnson Careers.

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