Principal Scientist, Biostatistics

Johnson & Johnson; Spring House (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a Principal Scientist, Biostatistics to be located in Spring House, PA or Raritan, NJ. The role provides input to study design, statistical analysis, and data interpretation across Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences.

Collaborate with QSCP and other scientists to ensure robust statistical delivery and regulatory-ready results. You will apply advanced techniques, lead study design optimizations, and drive cross-functional

Qualifications

• Master's degree preferred in biostatistics, statistics, bioinformatics, or a related field.

Responsibilities

• Provide input to design and execution of studies across Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences.
• Collaborate with QSCP and other drug-development scientists to address statistical aspects of programs.
• Lead in optimizing study designs and perform scenario simulations and sample-size calculations.
• Apply advanced statistical methods to research data, ensuring regulatory compliance and high-quality outputs.
• Guide teammates on study design improvements and contribute to cross-functional partnerships.

Job description

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

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 jnj.com

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 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.

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

We are searching for the best talent for a Principal Scientist, Biostatistics to be located in Spring House, PA or Raritan, NJ.

Purpose: The Principal Scientist provides input to the design and execution of studies and experiments for Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences programs at J&J Innovative Medicines (J&J IM), with minimal supervision. Support is provided to statistical analysis, interpretation, and reporting or communication of data evidence towards programs for research, development, and/or marketed product needs in J&J IM.

This individual will collaborate with Quantitative Sciences & Clinical Pharmacology (QSCP) functions and other drug development scientists to support statistical aspects of key business and regulatory commitments, contributes to program plans, and represents Statistics & Decision Sciences (SDS) in various teams or working groups. They will practice J&J leadership principles and values aligned with the company's Credo and purpose.

You will be responsible for:

• Exhibiting advanced proficiency in data analytics, grounded in statistical principles with a proven record of effectively supporting programs.
• Demonstrating competence in using pertinent computational tools for research objectives related to studies, experiments, or trials, including full proficiency in R and SAS, along with familiarity with other relevant computational tools, including innovative data-adaptive methods and artificial intelligence.
• Ensuring the application of high-quality statistical methodologies in assigned projects, showcasing an understanding of the disease/scientific/functional area and compliance with health authority standards.
• Integrating quantitative sciences with disease or functional area requirements, balancing scientific and business needs.
• Providing leadership in optimizing study designs to meet objectives, and supports scenario simulations and sample size calculations informed by technical and area specific knowledge.
• Proactively identifying complexities related to scientific, statistical, regulatory, operational, and partnership aspects. Progresses to more complex programs upon mastering standard ones.
• Identifying and implementing advanced statistical techniques to address complex project or program features.
• Serving as a recognized leader, offering guidance to the team on optimizing study or trial designs in accordance with study or indication level objectives.
• Improving inferential insights while minimizing time, cost, and study risk.
• Collaborating cross-functionally to identify and resolve issues.
• Engaging in process improvement and standards development initiatives.
• Building cross-functional partnerships with internal colleagues and external partners (e.g., Contract Research Organizations (CROs), consultants) to achieve results for project-specific needs, focusing on enhancing communication, efficiency, and productivity.
• Working within SDS and QSCP for unified and integrated quantitative input in drug development.
• Delivering high-quality and timely outputs as evaluated by partners such as the project team, clinical trial team, and the Statistics Area Head.
• Identifying vital external scientific and statistical trends, driving the advancement of statistical methodologies through scholarly publications.
• Participating in interactions with health authorities.

Qualifications/Requirements

Education: A minimum of a Master's degree wi