Senior Principal Scientist, Biostatistics Full-time NEW

Senior Principal Scientist, Biostatistics

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.

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, Titusville, New Jersey, United States of America

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.

Purpose: Leading expert individual contributor who works independently to own major portions of Bio statistical research and development projects.

You will be responsible for:

• Exhibits advanced data analytics expertise through applied experience, grounded in statistical principles with a strong record of effectively supporting programs.
• Demonstrates proficiency in utilizing computational tools to analyze and visualize data for research objectives related to studies, experiments, or trials. This includes full proficiency in R and SAS, along with familiarity with other relevant computational tools, including innovative data-adaptive methods and artificial intelligence.
• Ensures 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.
• Acts with accountability, agility, and transparency.
• Applies statistical expertise in drug development to improve experimental design, modeling, analysis planning and execution, interpretation, and statistical communications.
• Demonstrates knowledge across multiple disease areas/targets within or across Therapeutic Areas (TAs). Understands both technical and scientific aspects of conducting research in a disease area, as well as the market/competitive landscape.
• Demonstrates thorough knowledge of pharmaceutical research and development strategies and execution.
• Proactively identifies and substantially helps solve complexities related to scientific, statistical, regulatory, operational, and partnership aspects.
• Engages in process improvement and standards development initiatives.
• Applies advanced statistical methodology with demonstrated integrated disease/scientific/functional area understanding and regulatory acceptability, to improve the probability of regulatory approval and product differentiation.
• Seen as a recognized leader in an area of technical expertise. Identifies and implements advanced statistical techniques to address complex project or program features.
• Demonstrates a proven history of proposing, assessing, and executing successful alternative or innovative approaches to statistical methodologies or business processes.
• Serves as a recognized leader, offering guidance to the team on optimizing study or trial designs in accordance with study or indication level objectives.
• Enhances inferential insights while minimizing time, cost, and study risk.
• Proven ability in problem-solving and troubleshooting at the program level, including supporting strategic scenario planning, quantitative decision-making, and regulatory support.
• Collaborates cross-functionally to identify and resolve issues.
• Identifies, directs, and executes statistical or business processes and tools that demonstrate an understanding of new and evolving demands and trends.
• Successfully addresses business needs through enhanced insights, productivity, and efficiency.

Impact:

• Demonstrates strong skills in building relationships across functions. Has established a strong and influential voice in SDS, Global Development (GD), and with TAs or Functional Areas (FAs) in helping teams with setting strategic directions and decision-making.
• Is accountable as a point of contact for a specific project or program (e.g., Clinical Trial Statistical Lead) and the management of all related project/program deliverables.
• Collaborates effectively with SDS colleagues and external partners to meet program needs.
• Represents Statistics & Decision Sciences on various teams ((e.g., Compound Development Team, Quantitative Sciences and Clinical Pharmacology (QSCP) matrix team), J&J IM senior management-level reviews (e.g. first in human committee, QS consulting interface meetings), working groups, and health authority interactions.
• Works within SDS and QSCP for unified and integrated quantitative input in drug development.
• Represents Statistics & Decision Sciences in cross-functional and intra-departmental teams or working groups pertaining to scientific or process initiatives.
• Builds 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. Able to serve as SDS representative for internal Due Diligence activities.
• Identifies vital external scientific and statistical trends, driving the advancement of statistical methodologies through scholarly publications.
• Engages actively in presentations at key forums and publishes work addressing business-related needs. Participates in interactions with health authorities.
• Contributes actively as a member of professional organizations via meetings and conferences, serving as an officer, event co-coordinator, or session chair.
• Works with cross pharma consortiums to develop industry standards. Authors scientific journal manuscripts. Peer reviews or edits manuscripts for professional journals.

Qualifications/Requirements:

• Master's Degree in Statistics with 10+ years exp OR PhD in Statistics with 7+yrs in related field of clinical data analysis experience, is required.
• Credo-based leadership consistent with J&J IM Leadership Imperatives to develop and persuasively deliver statistical strategy and scientific advice to development programs.
• Displays a proactive approach and cultivates a growth mindset for personal development.
• Keeps up-to-date with the changing landscapes in drug development and statistical methodology, and shows adaptability to optimize contributions to the J&J IM pipeline.
• Continuously grows global and big picture perspectives.
• Exhibits strong written, oral, and interpersonal communication skills, and demonstrates proficiency in collaborating with non-statisticians by translating intricate statistical concepts for drug research and development partners.
• Effectively communicates statistical findings to program stakeholders and broader non-technical audiences utilizing interactive graphical tools.
• Supervises contractors/special assignment personnel/interns/co-ops as required.
• Shares knowledge within and across functions. Leverages experience to mentor emerging leaders in techniques, processes, and responsibilities.
• Takes responsibility and accountability for the quality and timeliness of project deliverables as assessed by stakeholders from respective projects or programs. Follows best practices for Good Clinical, Manufacturing, Laboratory, or other pertinent GxP activities and requirements, including Data Integrity.
• Complies with organization and company standard operating procedures in a timely fashion, such as required training and project time reporting.
• Demonstrates understanding and alignment with pertinent regulatory guidance.
• Ensures that documents, programs, and all other deliverables are consistent and adhere to project and company standards.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Advanced Analytics, AI Judgement Integration, Biostatistics, Clinical Data Management, Clinical Trial Protocols, Collaboration, Compliance Management, Data Privacy Standards, Good Clinical Practice (GCP), Proactive Behavior, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Representing, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Tactical Planning, Technical Credibility

The anticipated base pay range for this position is :

$140,000.00 – $241,500.00

Additional Description for Pay Transparency:

Subject to the terms of