Senior Principal Scientist, Biostatistics

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

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 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.

Learn more at are searching for the best talent for Senior Principal Scientist Biostatistics.

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

You will be responsible for:

Expertise

• 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.
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• 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:

• Masters Degree in Statistics with 10 years exp OR PhD in Statistics with 7yrs 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 internal employees contact AskGS to be directed to your accommodation resource.

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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 :

$140000.00 - $241500.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: Experience:

Staff IC