Principal Statistical Programming Lead

The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures.
As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers.

The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality.

In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams.
In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects.

Principal Responsibilities:
• Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests.
• Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes.
• Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities.
• Performs comprehensive review of, and provides input into, project requirements and documentation.
• Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations.
• As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.
• Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads.

• Contributes to and may lead departmental innovation and process improvement projects and may contribute programming expertise to cross functional projects/initiatives. May play the role of a Delivery Unit/Disease Area Expert.
• Ensures continued compliance of project/programs and required company and departmental training, time reporting, and other business/operational processes as required for position.

Clinical Programming:
• Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards.
• Responsible for implementation of data tabulation standards.
• Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring.

Statistical Programming:
• Responsible for implementation of data and analysis standards ensuring consistency in analysis dataset design across trials within a program.

Principal Relationships:

The Principal Programming Lead reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities.
• Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations.
• Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources.
• External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups.

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. 12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. Experience in early development/clinical pharmacology studies (BA/BE, DDI, FE etc.) will be preferable.
• 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 rapidly changing organizations and business environments.
• Experience managing the outsourcing or externalization of programming activities in the clinical trials setting (e.g., Working with CROs, academic institutions) preferred experience.
• Demonstrated experience managing the outsourcing or externalization of clinical programming activities in the clinical trials 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.

Other:
• Innovative thinking allows for optimal design and execution of programming development strategies.
• Development and implementation of a business change/innovative way of working.