Statistical Programming Lead
3 weeks ago
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.
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Statistical Programming Lead
4 weeks ago
Mumbai, India Johnson & Johnson Full timeIntegrated Data Analytics and Reporting (IDAR) Position Title*: Statistical Programming Lead Position 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...
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Statistical Programming Lead
4 weeks ago
Mumbai, Maharashtra, India Johnson & Johnson Full timeIntegrated Data Analytics and Reporting (IDAR) Position Title*: Statistical Programming Lead Position 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...
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Statistical Programming Lead
3 weeks ago
Mumbai, India Johnson and Johnson Full timeIntegrated 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...
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Mumbai, India Pfizer Full timeThis role is a hands-on statistical programmer supporting study and asset teams in the delivery of less complex statistical programming deliverables - Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures, and qc work for which they are responsible - Ensures adherence to high quality programming standards in their...
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