Statistical Programming Director jobs in United States
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Johnson & Johnson · 1 month ago

Statistical Programming Director

Johnson & Johnson is a leading company in healthcare innovation, dedicated to developing smarter and less invasive treatments for complex diseases. The Statistical Programming Director will lead programming strategy and delivery across therapeutic areas, ensuring compliance and optimizing processes while managing a team to meet business needs.

Hospital & Health Care
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Accountable for the operational delivery, quality, and compliance of the assigned portfolio across one or more therapeutic areas and/or disease area strongholds, encompassing all phases of development. Provides input and oversight of regulatory submission strategy related to functional deliverables, where applicable
Collaborates with departmental leadership to oversee and coordinate sourcing, budget planning, and strategy for the assigned area
Contributes to decisions on business and sourcing strategy, processes, and resource allocation across sites
Accountable for driving the overall technical capability strategy and process solutions to enhance productivity, quality, performance, and innovation within the functional area
Identifies and drives process optimization and innovation within the assigned area, ensuring alignment of processes and procedures across the organization
Manages process and policy compliance in accordance with global, local and project requirements
Ensures appropriate documentation and/or corrective and preventative action planning related to process exceptions or deviations
Collaborates and partners with cross-functional leadership to address and resolve issues, championing best practices
Collaborates with vendors to optimize sourcing strategies and decisions, ensuring appropriate oversight and governance of vendor engagements
Develops and maintains policies and standards applicable across the organization, ensuring compliance within the assigned area
Regularly meets with direct reports to ensure consistency and appropriate progress towards project goals
Accountable for attracting, hiring, and retaining top talent, managing performance, and actively supporting talent development and succession planning. Responsible for making decisions related to the management of assigned personnel and local administration including space allocation, supplies, budget, and travel, etc
Ensures training compliance and development of appropriate job skills for assigned personnel and organization. Oversees work allocation for direct reports, providing coaching and guidance as necessary
Collaborates with departmental leadership and partner and stakeholder functions to ensure alignment of departmental roles and responsibilities
Contributes to the development and implementation of the functional strategy and vision to meet current and future needs, staying updated with industry trends and policies
Provides strategic input and direction in the evaluation and reassessment of departmental policies, procedures, best practices and sponsorship of initiatives and projects
Owns one or more business processes/procedures, ensuring they are current and efficient
Participates in and/or leads global cross-functional and cross-company initiatives, as applicable

Qualification

Statistical ProgrammingLeadershipProject ManagementBiostatisticsRegulatory Affairs ManagementQuality Assurance (QA)Clinical Practice (GCP)Data Privacy StandardsCompliance ManagementDeveloping OthersInclusive LeadershipProgram ManagementProject Integration ManagementQuantitative ResearchStandard Operating Procedure (SOP)Advanced AnalyticsMentorship

Required

Bachelor's degree (e.g., BS, BA) or higher and/or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth)
Approx. 10+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry
Approximately 10+ years clinical programming, data management or statistical programming experience within the pharmaceutical/clinical trial environment with proven experience in leadership roles
Excellent people leadership skills
People management experience of 5+ years is strongly preferred
Extensive understanding of programming practices and systems with strong general knowledge of clinical operations
Established track record working on cross-functional teams in a matrix environment and partnering with/managing stakeholders and customers
Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g. working with CROs, academic institutions)
Excellent communication, leadership, influencing and decision-making skills, and proven ability to foster team productivity and cohesiveness, acting as a change agent, and adapting to rapidly changing organization and business environments
Demonstrated people management skills and experience in staff performance management and people development
In-depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts
Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies

Preferred

Advanced Analytics
Bioethics
Biostatistics
Collaborating
Compliance Management
Data Privacy Standards
Developing Others
Good Clinical Practice (GCP)
Inclusive Leadership
Leadership
Mentorship
Program Management
Project Integration Management
Quality Assurance (QA)
Quantitative Research
Regulatory Affairs Management
Standard Operating Procedure (SOP)
Statistical Analysis Systems (SAS) Programming

Benefits

Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Company’s consolidated retirement plan (pension)
Savings plan (401(k))
Company’s long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 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
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

Company

Johnson & Johnson

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At Johnson & Johnson, we believe health is everything.

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)

Funding

Current Stage
Late Stage

Leadership Team

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Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
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Joaquin Duato
Chairman of the Board and Chief Executive Officer
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Company data provided by crunchbase