Drives the strategy and planning, execution, and completion of all programming activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency
Leads and designs programming strategy across assigned portfolio over the life cycle of a program to ensure consistency, efficiency, and quality of programming deliverables
Proactively evaluates and manages resource demand, allocation, utilization, and delivery to meet current and future business needs
Ensure timely and effective maintenance of functional planning systems
May include forecasting related to potential in-licensing and acquisitions
Independently and effectively manages issue escalations, adopting appropriate escalation pathways
Collaborates with cross-functional and external partners on programming related deliverables for co-development programs and defining data integration strategy of the assigned programs/projects
Ensures training compliance and development of appropriate job skills for assigned personnel
Contributes to the development of functional vendor contracts and oversees delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates
Serves as the primary point of contact for sourcing providers and is responsible for establishing a strategic partnership
Drives the enhancement of functional, technical and/or scientific capabilities within C&SP and shares best practices
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
Accountable for actively identifying opportunities, evaluating, and driving solutions to enhance efficiency and knowledge-sharing across programs, value streams and the department
Serves as departmental resource in areas of process and technical expertise
Stays current with industry trends and policies related to Programming
Leads departmental innovation and process improvement projects and as required, may contribute programming expertise to cross functional projects/initiatives
Provides strategic direction within Delivery Unit initiatives and projects
Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards
Responsible for development and implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program.

Requirements

Bachelor's degree (e.g., BS, BA) is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth)
8+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry
Expert knowledge of data structures and relevant programming languages for data manipulation and reporting including Python
In-depth knowledge of programming practices (including tools and processes)
In depth knowledge of regulatory guidelines (e.g., ICH-GCP)
Project, risk, and team management and an established track record leading teams to successful outcomes
Excellent planning and coordination of deliverables
Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors
Excellent written and verbal communications skills (in English)
Demonstrated experience managing the outsourcing or externalization programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred
Expert CDISC Standards knowledge.

Benefits

medical, dental, vision, life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Pythondata structuresprogramming practicesdata manipulationreportingCDISC Standardsregulatory guidelinesanalysis dataset designclinical databasesforecasting

Soft Skills

project managementrisk managementteam managementplanningcoordinationcollaborationcommunicationproblem-solvinginnovationprocess improvement