Head, Statistical Programming & Analysis
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Head, Statistical Programming & Analysis to be based in either Spring House PA, Horsham PA, Raritan NJ or Titusville NJ , Beerse, Belgium or High Wycombe, UK .
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.
We discover and develop innovative medical solutions to address unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Visit http://www.JanssenRnD.com to learn more.
An influential leader with advanced understanding of the drug development process, with significant experience in overseeing clinical statistical programming activities and assuring timely completion of reporting and analysis for all areas of Clinical Research.
As well-established leader, with a recognized track record of organizational development and leadership, driving all aspects of the statistical programming discipline leading to effective and efficient delivery of the Janssen portfolio across multiple therapeutic areas and all phases of development.
Provide leadership role in department process development and optimization of related clinical research activities.
Accountable for the development of all employees within the department including management development and training to meet current and future business needs.
Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
- Define vision and lead the Statistical Programming & Analysis function by providing technical and business leadership
- Accountable for operational delivery, quality, compliance and timelines of reporting and analysis for all areas of supporting the Janssen R&D portfolio.
- Ensures departmental policies, training, and standards are adequate to support drug development for regulatory approval. Be accountable for full compliance to all regulatory requirements
- Promote and ensure partnership with partner functions at all levels to ensure seamless collaboration on the projects for all deliverables and enable innovation and strategic input through providing high-end programming solutions for data exploration, design evaluation etc.
- Build and deploy innovative technical solutions, enhancing effectiveness and efficiency of the programming organization.
- Drives business efficiency, financial planning and cost basis; Stay current, anticipate internal and external drivers and opportunities to devise and implement cross-functional strategies to maximize productivity and efficiency through use of effective business process, global corporate standards, development and utilization of strategic alliances with external partners to ensure high quality operational and strategic management of the global Statistical Reporting function
- Provides leadership to the Statistical Programming & Analysis team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication; establishing Janssen Data Analysis team as an industry leader
- Develop and implement Functional Excellence for Statistical Programming & Analysis by defining strategic goals and sponsoring/leading the associated initiatives. Communicate with IDAR LT and ensure that initiatives' objectives and priorities are in line with IDAR strategy.
- Partner with Data Delivery Head to drive end to end standardization and process simplification.
- Accountable for departmental policies, procedures, training and standards.
- Policy and standards development and compliance as it relates to delivery of statistical programming
- Participates in and/or lead cross-functional and cross-company initiatives, as applicable.
RESPONSIBILITY FOR OTHERS:
- This position reports to Head IDAR. The job holder will be expected to provide leadership to Statistical Programming organization by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
- This position is responsible for a team of more than 250 Janssen Employees globally, in addition to necessary external support based on portfolio and project demands.
- Provide effective leadership to his/her team members responsible for supporting the Janssen R&D portfolio of clinical studies.
- Set team goals and objectives, periodic performance evaluation and feedback, and the development of all employees within functional scope
- Ensure compliance with department SOP's, WI's, policies and regulatory guidance documents and all associated trainings
- Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
- Regularly meet with team members at all levels to ensure appropriate progress within functional scope.
- Estimate required budget covering Capex, Opex and Resource needs and effectively manage same.
- University/college degree is required.
- An advanced degree (e.g. Masters, MBA, MD, PhD) is preferred.
- 15 years industry experience is required
- 5+ years of experience in a senior managerial position leading people is required.
- Proven people leadership capabilities is required.
- Excellent understanding of clinical development, quality and regulatory standards and policies relevant to Statistical Programming (e.g. GCP, ICH) is required.
- Expert knowledge of/experience with SAS and other relevant programming software is required.
- The ability to lead, manage and develop a high functioning diverse team and to build a department to enable industry-leading Statistical Programming Organization is required.
- A thorough understanding of clinical research processes is required with demonstrated expertise in deploying Statistical Programming solutions supported by technology is required.
- Proven track record in working across a matrix organization and demonstrates expert skills in building partnerships, negotiating agreements; excels at collaboration is required.
- Ability to travel, domestic and international, up to 20%
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC. (6084)
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