The Software Devl Manager (Senior Python & R) is a senior technical individual contributor responsible for end-to-end ownership of clinical data programming solutions across complex and/or multiple clinical studies.

This role serves as a technical authority within Clinical Data Management, leading advanced Python and Rbased data transformation, data review, analytics, and automation activities while ensuring compliance with clinical standards, regulatory requirements, and inspection readiness throughout the study lifecycle.

Key Responsibilities :

1. Clinical Data Programming Leadership :

- Lead the design, development, and maintenance of advanced Python and R programs to support :

1. Clinical data cleaning and transformation

2. Data review, metrics, and analysis

3. Study-level and program-level reporting

- Provide technical ownership of downstream CDM programming deliverables as defined in the Data Management Plan (DMP).

- Translate protocol and DMP requirements into scalable, compliant programming solutions.

- Act as a subject-matter expert in the application of CDISC standards (SDTM) for clinical data review and transformation.

- Architect and implement reusable Python/R frameworks, libraries, and utilities.

- Lead or contribute to automation initiatives to reduce manual data review and improve efficiency.

- Drive standardization and best-practice initiatives within CDM programming.

- Provide technical mentorship and guidance to Grade 130/140 programmers.

2. Technical Requirements :

- Strong SQL and data manipulation skills.

- Extensive experience working with clinical trial data.

- Strong applied knowledge of CDISC / SDTM.

- Proven experience working in regulated clinical data environments.