Statistical Programming Lead

4 weeks ago

Mumbai, Maharashtra, India Johnson & Johnson Full time

Integrated Data Analytics and Reporting IDAR Position Title Statistical Programming LeadPosition Summary The 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 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 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 oversees programming team activities and provides technical and project specific guidance to programming team members to ensure quality and on-time 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 effectively with statistical programming and cross-functional team members and counterparts to achieve project goals As applicable oversees 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 complex 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 increasing 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 Bachelor s 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 increasing responsibility preferably in a pharmaceutical clinical trial environment Advanced knowledge of relevant statistical programming languages including SAS required other relevant programming languages e g R Python etc preferred and data structures Demonstrated experience planning and coordinating programming activities and leading teams Demonstrated experience working with cross functional stakeholder and teams Working knowledge of regulatory guidelines e g ICH-GCP and relevant clinical R D concepts Basic project management skills Demonstrated written and verbal communication skills eQuest

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