Senior Statistician

Johnson & Johnson Innovative Medicine•Somerville, NJ

1d•Hybrid

About The Position

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. 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 Johnson & Johnson Innovative Medicine (JJIM) Research & Development, L.L.C., is recruiting a Senior Statistician to be located at Raritan, NJ, or Spring House, PA. (remote may be considered) The Senior Statistician 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 Innovative Medicine. This position supports statistical aspects of business-critical and/or regulatory commitments. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver. 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 guidances. 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 Statistics & Decision Sciences (SDS) management. Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings. Contributes positively to SDS team dynamics with a clear understanding of the SDS vision. 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. Discovery & Translational Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers. Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed. Manages multiple projects. Documents projects in sufficient detail for reproducibility. Manufacturing & Toxicology Serves as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers. Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed. Manages multiple projects. Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories. Medical Affairs Provides statistical support to Medical Affairs studies and assumes responsibilities for planning, design and analysis of randomized clinical trials, observational studies and/or patient registries for post marketing commitments/requirements and reporting related activities. Applies sound statistical thinking and computational abilities in support of Medical Affairs goals & objectives. Contributes in the planning, design, conduct and analysis for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support; Develops statistical analysis plans (SAPs) and data presentation specifications (DPSs); Provides statistical support for all LCM/regulatory-submission related activities; Interacts with other Medical Affairs functional groups (e.g., HECOR/Epidemiology, Market Access and publication teams); in close partnership with statistical lead, interacts with outside investigators (KOLs and vendors) in the preparation of scientific presentations and manuscripts and pursues implementation of robust statistical analyses in support of business-critical evidence generation; Explores and implements innovative statistical methods. Interfaces Internal: Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance. External: Contracted Partners, Academia, Professional Societies, Private and Public Consortia.

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.
Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.
Good written, oral, and interpersonal communication skills.

Nice To Haves

Advanced Analytics
Biostatistics
Clinical Trials
Collaborating
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 in J&J Innovative Medicine.
Supports statistical aspects of business-critical and/or regulatory commitments.
Abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.
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 guidances.
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 Statistics & Decision Sciences (SDS) management.
Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings.
Contributes positively to SDS team dynamics with a clear understanding of the SDS vision.
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.
Serves as initial consultation contact for new projects.
Maintains and grows customer base, and builds loyal relationships with customers.
Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed.
Manages multiple projects.
Documents projects in sufficient detail for reproducibility.
Provides statistical support to Medical Affairs studies and assumes responsibilities for planning, design and analysis of randomized clinical trials, observational studies and/or patient registries for post marketing commitments/requirements and reporting related activities.
Applies sound statistical thinking and computational abilities in support of Medical Affairs goals & objectives.
Contributes in the planning, design, conduct and analysis for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support
Develops statistical analysis plans (SAPs) and data presentation specifications (DPSs)
Provides statistical support for all LCM/regulatory-submission related activities
Interacts with other Medical Affairs functional groups (e.g., HECOR/Epidemiology, Market Access and publication teams)
in close partnership with statistical lead, interacts with outside investigators (KOLs and vendors) in the preparation of scientific presentations and manuscripts and pursues implementation of robust statistical analyses in support of business-critical evidence generation
Explores and implements innovative statistical methods.

Benefits

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits: – Vacation – up to 120 hours per calendar year – Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year – Holiday pay, including Floating Holidays – up to 13 days per calendar year – Work, Personal and Family Time - up to 40 hours per calendar year

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