Senior I Statistical Programming Lead

The Senior Statistical Programming Lead is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting activities and programming teams in accordance to departmental processes and procedures. This position is accountable for the planning, oversight and delivery of statistical programming activities supporting one or more clinical projects, compounds and/or submissions generally of low-medium complexity/criticality.

The Senior Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to programming teams.

As an experienced Statistical Programmer this position applies advanced technical and problem-solving skills to complete programming activities of high complexity that may benefit multiple project teams. In addition, the Senior Statistical Programming Lead may contribute advanced knowledge and technical skills to Therapeutic Area or departmental innovation and process improvement projects.

Principal Responsibilities

As a Programming Lead;

• Accountable for Statistical Programming team delivery for one or more clinical projects generally of low to medium complexity, scope or criticality.
• Coordinates and supervises programming team activities and provides technical and project specific mentorship to programming team members to ensure quality and timely statistical programming deliverables in compliance with departmental processes and procedures.
• Develops detailed programming strategy, specifications and plans the programming deliverables for a one or more clinical projects. May act as a section lead of programming activities supporting a clinical program, compound or submission.
• Performs comprehensive review of, and provides input into, project requirements and documentation.
• Collaborates optimally with statistical programming and cross-functional team members and counterparts to achieve project goals.
• As applicable, coordinates statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.

As an experienced Statistical Programmer;

• Designs and develops programs in support of sophisticated clinical data analysis and reporting activities.
• Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality.
• May contribute to or lead others in an area of expertise that results in solutions growing the efficiency and quality of deliverables across multiple projects.
• May play the role of a Therapeutic/Disease Area Expert contributing to standards strategy and definition and providing expertise for a specific Therapeutic/Disease area across value streams.
• Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.
• May contribute to departmental innovation and process improvement projects.

Principal Relationships

• Reports into people manager position within the functional area. Accountable to the Statistical Programming Portfolio Lead for assigned programming activities and responsibilities.
• Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within the function, Data Management, Regulatory Medical Writing.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Clinical Trial Lead, Quantitative Sciences, Biostatisticians, Regulatory, Clinical - Primary interfaces within clinical project (trial), program, and submission teams.
• External contacts include but are not limited to external partners including CROs.

Qualifications - External

• Bachelors degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 6-8 years programming experience with growing responsibility, preferably in a pharmaceutical/clinical trial environment.
• Advanced knowledge of relevant statistical programming languages including SAS (required), other relevant programming languages (eg R, Python etc preferred), and data structures.
• Proven experience planning and coordinating programming activities and leading teams.
• Proven experience working with cross functional stakeholder and teams.
• Solid understanding of regulatory guidelines (eg ICH-GCP) and relevant clinical R&D concepts.
• Basic project management skills.
• Demonstrated written and verbal communication skills.