Job Description

Summary of Position:

The Senior Data and Reporting Programmer is a key contributor responsible for quality, timely and cost efficient execution of all clinical and operational programming aspects of assigned studies or project activities.

Key Responsibilities:

Leads programming activities for clinical studies or assigned projects including requirements analysis, planning and tracking, development of programs and validation of deliverables.

Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope),

Provide input into statistical programming solutions and/or ensure their efficient implementation.

In consultation with the Statistician, responsible for development of programming specifications of analysis datasets and pooled datasets.

Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications

Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.

Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.

Key Requirements/Minimum Qualifications:

• Quality and timeliness of all deliverables for assigned studies or project-level activities.
• Ability and effectiveness in leading activities for study or project.
• Compliance with internal and external standards as measured by audit findings.
• Works effectively under minimal supervision of supervisor or Project Programmer within a Franchise who is responsible for the overall data and reporting strategy for the project.
• At least 5 years of relevant programming experience preferably in the pharmaceutical or device industry
• At least 2 years of proven ability to lead programming activities as Trial Programmer or Project programmer
• Multilingual programming capability
• Strong SAS programming skills including development and use of macros
• Must have 2 or more other programming language expertise: Python, VBA, R, C#, JAVA

Work hours: 1 PM to 10 PM IST

Relocation assistance: Yes

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