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Location

Secunderabad | India

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Job description

The Statistical Programming team is a dynamic function where we are empowered to experiment, explore and progress beyond the boundaries of best-in-class Statistical Programming analysis. From a collaborative effort with Data Management, Clinical Study Teams, Statisticians, medical / scientific writing teams, publication teams, we analyze tons of data, deriving meaningful insights that enable us to deliver innovative medicines to millions of patients worldwide.

Your key responsibilities:
Your responsibilities include, but are not limited to:

Responsible for managing project level activities within Product Lifecycle Services (PLS). Act as the programming functional lead on customers project teams. Participate in project team meetings. Determine an efficient project programming strategy that utilizes customers standards and procedures. Develop project-level programming specifications for analysis datasets and pooled datasets for a project.

Lead the production of statistical outputs for clinical study reports, publications, and market promotions. Ensure the quality control of all programs, specifications and statistical outputs within a study project.

Ensure that programming-related documents are consistent, and comply with Data Sciences and customers standards, by reviewing case report forms, statistical analysis plans, data structures specifications, and specifications for tables, listings and figures. Archival of project programs and associated documentation.

Mentor programmers in the functional expertise required for project support. Support the development of, and the training of users in, new programming applications.

Develop advanced, general-purpose programming functions for deployment across multiple projects. Maintain advanced knowledge of programming languages (e.g., SAS and R).

Manage the outsourcing of programming activities from Data Science to an approved vendor in accordance with Scientific Services vendor management procedures.

Role Requirements

Essential:

Proven experience in development of advanced programming functions with high programming efficiency; strong programming and problem-solving skills

Proven experience in leading programmer support for multiple clinical trials and submission activities (or equivalent) .

Desirable requirements:

Good understanding of global clinical trial / project practices, procedures, methodologies. Good understanding of regulatory requirements relevant to statistical programming (e.g. Good Clinical Practice).

Good knowledge of office tools.

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