Position Summary:
The China Head, Clinical Statistical Programming (CSP) is a highly experienced Functional Leader with expert knowledge of CSP strategy, concepts and processes. This position requires expert people leadership skills with the capability to effectively manage statistical programming support across a large portfolio, typically across multiple Therapeutic Areas.
This position is accountable for CSP strategy and delivery for all therapeutic area in accordance to 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 a people and organizational leader, the China Head is accountable for the recruitment, performance management, talent development and resource management within the China CSP team to meet current and future business needs, contributing to the overall talent management and sourcing strategy for the department.
As a member of the IDAR CSP Leadership Team, this position provides input into overall departmental strategy and drives the development and continuous improvement of departmental policies, procedures, training and standards.
Principal Responsibilities:
As Functional Leader
• Oversees and ensures effective CSP delivery across all Therapeutic Area/Value Stream Portfolio. Where applicable, provides input to and oversight of regulatory submission strategy as it relates to functional deliverables.
• In collaboration with departmental leadership, oversees and coordinates sourcing and budget planning and strategy.
• Contributes to decisions on departmental business and sourcing strategy, processes and resource allocation.
• Identifies and drives process optimization and innovation and ensures alignment of processes and procedures across partner functions and key stakeholders.
• Manages process and policy compliance in line with global, local and project requirements. Ensures appropriate documentation and/or corrective and preventative action planning relating to process exceptions or deviations.
• Collaborates and partners with cross-functional leadership to drive issue escalation/resolution and champions best practices.
• Collaborates with vendors to optimize sourcing strategies and decisions. Ensures appropriate oversight and governance of vendor engagements.
As an Organization and Functional Area People Leader
• Accountable for attracting and retaining top talent, managing performance and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication.
• Ensures training compliance and development of appropriate job skills for assigned personnel and organization. Oversees work allocation for line reports and provides coaching and guidance as necessary.
• Responsible for local administration and decision making associated with the management of assigned personnel.
• 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 functional strategy and vision to meet current and future needs, stays current with related industry trends and policies.
• Provides strategic input into the evaluation and reassessment of departmental policies, procedures and best practices
• Provides strategic direction and/or sponsorship of departmental and/or cross functional initiatives and projects.
• Owns one or more department procedures, ensuring the processes are up to date and efficient.
• Participates in and/or leads global cross-functional and cross-company initiatives, as applicable.
Principal Relationships:
• This position reports to the Global Head, IDAR Clinical Statistical Programming.
• Functional Contacts within IDAR include but are not limited to CSP Leadership Team and staff, Data Management Central Monitoring TA/regional Heads, Regulatory Medical Writing.
• Functional contacts within Johnson Johnson Innovative Medicine (as collaborator or peer) may include but are not limited to employees from other departments within Global Development, Quantitative Sciences, Bio Research Quality Compliance, Delivery Unit, Regulatory Affairs and Operations, Human Resources, Finance, IT.
• External contacts include but are not limited to external partners including CROs and industry peers and working groups.
Position Summary:
The China Head, Clinical Statistical Programming (CSP) is a highly experienced Functional Leader with expert knowledge of CSP strategy, concepts and processes. This position requires expert people leadership skills with the capability to effectively manage statistical programming support across a large portfolio, typically across multiple Therapeutic Areas.
This position is accountable for CSP strategy and delivery for all therapeutic area in accordance to 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 a people and organizational leader, the China Head is accountable for the recruitment, performance management, talent development and resource management within the China CSP team to meet current and future business needs, contributing to the overall talent management and sourcing strategy for the department.
As a member of the IDAR CSP Leadership Team, this position provides input into overall departmental strategy and drives the development and continuous improvement of departmental policies, procedures, training and standards.
Principal Responsibilities:
As Functional Leader
• Oversees and ensures effective CSP delivery across all Therapeutic Area/Value Stream Portfolio. Where applicable, provides input to and oversight of regulatory submission strategy as it relates to functional deliverables.
• In collaboration with departmental leadership, oversees and coordinates sourcing and budget planning and strategy.
• Contributes to decisions on departmental business and sourcing strategy, processes and resource allocation.
• Identifies and drives process optimization and innovation and ensures alignment of processes and procedures across partner functions and key stakeholders.
• Manages process and policy compliance in line with global, local and project requirements. Ensures appropriate documentation and/or corrective and preventative action planning relating to process exceptions or deviations.
• Collaborates and partners with cross-functional leadership to drive issue escalation/resolution and champions best practices.
• Collaborates with vendors to optimize sourcing strategies and decisions. Ensures appropriate oversight and governance of vendor engagements.
As an Organization and Functional Area People Leader
• Accountable for attracting and retaining top talent, managing performance and actively supporting talent development and succession planning. Ensures organizational effectiveness, transparency, and communication.
• Ensures training compliance and development of appropriate job skills for assigned personnel and organization. Oversees work allocation for line reports and provides coaching and guidance as necessary.
• Responsible for local administration and decision making associated with the management of assigned personnel.
• 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 functional strategy and vision to meet current and future needs, stays current with related industry trends and policies.
• Provides strategic input into the evaluation and reassessment of departmental policies, procedures and best practices
• Provides strategic direction and/or sponsorship of departmental and/or cross functional initiatives and projects.
• Owns one or more department procedures, ensuring the processes are up to date and efficient.
• Participates in and/or leads global cross-functional and cross-company initiatives, as applicable.
Principal Relationships:
• This position reports to the Global Head, IDAR Clinical Statistical Programming.
• Functional Contacts within IDAR include but are not limited to CSP Leadership Team and staff, Data Management Central Monitoring TA/regional Heads, Regulatory Medical Writing.
• Functional contacts within Johnson Johnson Innovative Medicine (as collaborator or peer) may include but are not limited to employees from other departments within Global Development, Quantitative Sciences, Bio Research Quality Compliance, Delivery Unit, Regulatory Affairs and Operations, Human Resources, Finance, IT.
• External contacts include but are not limited to external partners including CROs and industry peers and working groups.
Education and Experience Requirements:
• Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) required. Advanced Degree (Master’s, PhD or equivalent preferred).
• Approximately 10 to 15 years of experience working in Statistical Programming or Biometrics organizations. within the pharmaceutical/clinical trial environment with proven experience in a leadership role.
• Strong people leadership capabilities and proven experience leading teams with the ability to foster team productivity and cohesiveness. People management experience of 5-7 years is strongly preferred.
• Extensive understanding of Statistical Programming practices and systems, with good general knowledge of clinical operations.
• Demonstrated experience developing talent using relevant personnel policies and procedures.
• Advanced knowledge of sourcing strategies and resource management.
• In-depth knowledge of project and risk management.
• Experience working in a cross-functional environment and demonstrated knowledge of industry trends relevant to Statistical Programming.
• In depth knowledge of regulatory guidelines (e.g. ICH-GCP), inter-departmental processes and relevant clinical RD concepts.
• Excellent leadership, stakeholder management and decision-making skills.
• Excellent oral and written communication skills, including effective negotiation and influencing skills.
• Demonstrated experience working in a customer focused environment.
Education and Experience Requirements:
• Bachelor’s degree or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth) required. Advanced Degree (Master’s, PhD or equivalent preferred).
• Approximately 10 to 15 years of experience working in Statistical Programming or Biometrics organizations. within the pharmaceutical/clinical trial environment with proven experience in a leadership role.
• Strong people leadership capabilities and proven experience leading teams with the ability to foster team productivity and cohesiveness. People management experience of 5-7 years is strongly preferred.
• Extensive understanding of Statistical Programming practices and systems, with good general knowledge of clinical operations.
• Demonstrated experience developing talent using relevant personnel policies and procedures.
• Advanced knowledge of sourcing strategies and resource management.
• In-depth knowledge of project and risk management.
• Experience working in a cross-functional environment and demonstrated knowledge of industry trends relevant to Statistical Programming.
• In depth knowledge of regulatory guidelines (e.g. ICH-GCP), inter-departmental processes and relevant clinical RD concepts.
• Excellent leadership, stakeholder management and decision-making skills.
• Excellent oral and written communication skills, including effective negotiation and influencing skills.
• Demonstrated experience working in a customer focused environment.