Statistical Programming Director – Integrated Data Analytics and Reporting
J&J Family of Companies
Johnson & Johnson Innovative Medicine is recruiting for a Statistical Programming Director to join our Integrated Data Analytics and Reporting team (IDAR). This position can be located in Titusville, NJ, Raritan, NJ or Spring House, PA, and follows a hybrid schedule of three days in the office and two days remotely per week.
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 https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Programming Director is a highly experienced functional area leader with expert knowledge of Programming strategy concepts and processes, industry standards and complex data structures and reporting solutions. This position requires expert project and people leadership skills with the capability to effectively manage programming support across a large portfolio across one or more therapeutic areas and/or disease area strongholds, and all phases of development. This position is accountable for programming strategy and delivery of the assigned area in accordance with company and departmental processes and procedures. In collaboration with departmental and cross-functional leadership/key stakeholders, this position also contributes to process optimization and innovation while ensuring appropriate cross-functional alignment and engagement when necessary. As such this position is accountable to drive the overall technical capability strategy and process solutions delivering increased productivity, quality, performance and innovation within the programming functional area.
As a people and organizational leader, this position is accountable for the recruitment, performance management, talent development, and resource management within their assigned area to meet current and future business needs, contributing to the overall talent management and sourcing strategy for the department.
As a member of the Clinical & Statistical Programming (C&SP) Leadership Team, this position provides input into overall departmental strategy and drives the development and continuous improvement of departmental policies, procedures, training, and standards.
Key Responsibilities:
Delivery Unit or Disease Area Stronghold Leader:
+ 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.
People Leader:
+ 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.
As a member of the Clinical & Statistical Programming Leadership Team shaping departmental strategy and implementation:
+ 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.
**Qualifications**
+ Bachelor's degree (e.g., BS, BA) or higher, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field is required. Advanced degree is preferred (e.g., Master, PhD).
+ At least 10 years clinical programming, data management or statistical programming experience within the pharmaceutical/clinical trial environment with proven experience in leadership roles is required.
+ People management experience of at least 5 years is required, including demonstrated experience in staff performance management and people development.
+ Extensive understanding of programming practices and systems with strong general knowledge of clinical operations is required.
+ Established track record working on cross-functional teams in a matrix environment and partnering with/managing stakeholders and customers is required.
+ Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is required.
+ In-depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts is required.
+ Demonstrated innovative thinking to allow for optimal design and execution of clinical development strategies is required.
+ 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 are required.
+ Knowledge of SAS and R are a plus.
+ This position can be located in Titusville, NJ, Raritan, NJ or Spring House, PA, and follows a hybrid schedule of three days in the office and two days remotely per week. Possible domestic and international travel of up to approximately 20% may be expected.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. The anticipated base pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
+ 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)).
+ This position is eligible to participate in the Company’s long-term incentive program.
+ Employees are eligible for the following time off benefits:
o Vacation – up to 120 hours per calendar year
o Sick time - up to 40 hours per calendar year
o Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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