Role & responsibilities

We are seeking an experienced Manager, Statistical Programmer with 10 - 17 years of clinical programming experience to lead statistical programming activities across multiple complex clinical research studies. The ideal candidate will have deep expertise in SAS (Base, Macros, SQL), strong knowledge of CDISC standards (SDTM/ADaM), TLF generation, and regulatory submissions (including E-submissions), with a proven ability to deliver high-quality programming solutions that meet sponsor and regulatory requirements. This role is responsible for establishing and driving programming standards, ensuring the adoption of robust and reproducible methodologies, overseeing programming documentation, specifications, code reviews, validation, and adherence to SOPs. The Manager will provide technical leadership, mentor statistical programmers, support cross-functional collaboration, manage project priorities and timelines, communicate project status to stakeholders, and contribute to process improvements and standardization initiatives while staying current with evolving statistical programming techniques and industry best practices. Experience presenting technical topics internally or externally and leading programming teams in a clinical research or CRO environment is highly desirable.

Preferred candidate profile

- Bachelor's or Master's degree in Statistics, Biostatistics,



Computer Science, Life Sciences, or a related scientific discipline.

- 10 - 17 years of statistical programming experience in the Pharmaceutical, Biotechnology, or CRO industry, with demonstrated experience leading programming teams and managing multiple clinical studies.

- Advanced expertise in SAS (Base, Macros, SQL), CDISC standards (SDTM/ADaM), TLF programming, and regulatory submissions (FDA, EMA, ICH).

- Strong understanding of GCP guidelines, clinical trial data standards, and end-to-end clinical study programming processes.

- Experience with programming validation, code reviews, development of reusable macros, programming documentation, and implementation of SOPs and best practices.

- Working knowledge of R, Python, or other statistical programming tools is an added advantage.

- Proven ability to manage multiple priorities, lead cross-functional collaborations, mentor and develop team members, and drive process improvements.

- Excellent analytical, problem-solving, communication, stakeholder management, and organizational skills with a robust focus on quality, compliance, and timely project delivery.

- Self-driven, detail-oriented, and capable of making independent decisions while fostering a collaborative and high-performing team environment.

📌 Manager, Statistical Programmer (Bengaluru)
🏢 Emmes
📍 Bengaluru