Senior Scientist, Biostatistics

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

3d•$109,000 - $174,800•Hybrid

About The Position

The Senior Scientist, Biostatistics provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in J&J. This position supports statistical aspects of business-critical and/or regulatory commitments. You will be responsible for: Expertise: Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability. Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues. Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content. Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidance. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity. Drug Development: Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution. Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support. Is accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects. Provides critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge. Collaboration: Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of management. Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings. Contributes positively to team dynamics with a clear understanding of the department vision. Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required. Process: Deep knowledge of data architecture, such as Data Standards. Recognizes the need and value of process standardization. External Engagement: Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.

Requirements

Ph.D. in Statistics or related field with minimum 0-2 years relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience.
Basic knowledge of SAS or R programming.
Good written, oral, and interpersonal communication skills.

Nice To Haves

Advanced Analytics
Biostatistics
Clinical Trials
Collaboration
Consulting
Critical Thinking
Data Privacy Standards
Data Quality
Data Savvy
Digital Fluency
Good Clinical Practice (GCP)
Quality Assurance (QA)
Report Writing
Standard Operating Procedure (SOP)
Statistical Analysis Systems (SAS) Programming
Statistics
Systems Development
Technologically Savvy

Responsibilities

Provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs.
Supports statistical aspects of business-critical and/or regulatory commitments.
Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience.
Is effective in the use of relevant computational tools for study, experiment, or trial research objectives.
Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.
Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues.
Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting.
Understands and aligns with relevant regulatory guidance.
Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Statistics Area Head.
Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards.
Follows best practices for Data Integrity.
Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution.
Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support.
Is accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects.
Provides critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of management.
Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings.
Contributes positively to team dynamics with a clear understanding of the department vision.
Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
Deep knowledge of data architecture, such as Data Standards.
Recognizes the need and value of process standardization.
Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.

Benefits

annual performance bonus
medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours