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Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Biostatistics
Job Category:
Scientific/Technology
All Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India
Job Description:
Principal I Portfolio Lead Clinical Programming
Position Summary:
This role is a highly experienced project leader with expert understanding of programming strategies, practices, methods, processes, technologies, industry standards and complex data structures, analysis, and reporting solutions.
This position is responsible for formulating the programming strategy across a portfolio of one or more programs, compounds, indications, disease areas within a delivery unit, with accountability for operational oversight and effective planning and execution of programming activities for their assigned portfolio while ensuring effective partnership with and management of stakeholders.
The role directly contributes to delivery of the J&J IM R&D portfolio through effective leadership and accountability while making autonomous decisions and recommendations that impact efficiency, timeliness, and quality of programming deliverables on large or complex clinical development programs and provides technical and project specific guidance to programming teams.The Portfolio Lead in C&SP also provides leadership and expertise in relevant technical areas and subject matter in support of process improvement, maintenance, and innovation initiatives and develops strong and productive working relationships with key stakeholders within IDAR in addition to broader partners, external suppliers, and industry groups. This position provides matrix leadership to departmental staff.
Clinical Programming:
• Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards.
• Responsible for implementation of data tabulation standard
Principal Responsibilities:
• Responsible for the end-to-end planning, execution, and completion of all programming activities within a portfolio, compound, disease area, indication in a Delivery Unit on time, within budget, and with high quality, consistent with departmental and company quality and compliance standards for assigned area.
• Provides mentorship and guidance to programmers and programming team leads as needed.
• Responsible for anticipation, early detection, prevention and management of risks and issues
impacting programming deliverables. Effectively manages program level programming issue
resolution activities, adopting appropriate escalation pathways as needed.
• Accountable for actively identifying opportunities, evaluating, and driving solutions to enhance
efficiency and knowledge-sharing across projects and programs.
• Designs programming strategy across assigned portfolio over the life cycle of a compound/ program to ensure consistency, efficiency, and quality of programming deliverables.
• Proactively evaluates and manages resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems. This includes forecasting related to potential in-licensing and acquisitions.
• Contributes to the development and oversight of functional vendor contracts and budget planning for projects within assigned portfolio including effective vendor management and escalation. As applicable, oversees activities outsourced to vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.
• Leads programming related aspects of regulatory agency inspections and J&J internal audits
ensuring real time inspection readiness for all programming deliverables.
• Provides input to submission strategy to regulatory agencies and ensures all programming
deliverables are complete and compliant.
• Contributes to and/or leads departmental innovation and process improvement projects and
development of disease or therapeutic area standards, training as required, may contribute
programming expertise to cross functional projects/initiatives.
Education and Experience Requirements:
Bachelor's degree (e.g., BS, BA) 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). Advanced degrees preferred (e.g., Master, PhD).
Experience and Skills Required:
• Approx. 10+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.
• In-depth knowledge of programming practices (including tools and processes).
• Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11)
Project, risk, and team management and an established track record leading teams to successful
outcomes.
• Excellent planning and coordination of project delivery.
• Established track record collaborating with multi-functional teams in a matrix environment and
partnering with/managing stakeholders, customers, and vendors.
• Excellent communication, leadership, influencing and decision-making skills, and demonstrated ability to foster team productivity and cohesiveness, adapting to evolving organizations and business environments.
• Experience managing the outsourcing or externalization of programming activities in the clinical trial setting (e.g., working with CROs, academic institutions) is preferred.
• Expert CDISC Standards knowledge.
• Expert knowledge of relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required for a Clinical Programming role.
• Excellent written and verbal communications and influencing and negotiation skills.
• Advanced knowledge of programming and industry standard data structures, thorough
understanding of end-to-end clinical trial process and relevant clinical research concepts
Required Skills:
Preferred Skills:
Advanced Analytics, Biostatistics, Clinical Data Management, Collaborating, Compliance Management, Critical Thinking, Data Privacy Standards, Good Clinical Practice (GCP), Organizing, Presentation Design, Program Management, Quality Assurance (QA), Regulatory Affairs Management, Research Documents, Standard Operating Procedure (SOP), Statistical Analysis Systems (SAS) Programming, Survey Design
