Senior Statistical Programmer - 12 Month Contract

Planet Pharma; India; On-site; INR 900,000 - 1,500,000; Full time

Job summary

A leading pharmaceutical company is seeking a highly experienced Clinical Statistical Programmer to independently lead programming activities across clinical studies. You will be responsible for designing, developing, and validating SAS programs for SDTM and ADaM datasets, ensuring compliance with CDISC and regulatory standards. This role involves collaboration with cross-functional teams and external vendors, and requires the ability to deliver high-quality outputs with minimal supervision.

Qualifications

• Deep expertise in SDTM and ADaM dataset development.
• Regulatory submission support experience.
• Ability to lead programming activities with minimal supervision.

Responsibilities

• Design, develop, and validate SAS programs for SDTM and ADaM.
• Produce submission‑ready datasets and documentation.
• Review and interpret SAPs and data management plans.
• Ensure deliverables comply with CDISC and regulatory standards.
• Lead programming activities for assigned studies with minimal supervision.
• Collaborate with cross-functional teams and external vendors on data standards.
• Perform quality control and validation of datasets and outputs.
• Identify and implement process improvements.

Skills

Expertise in SDTM

Expertise in ADaM

SAS programming

Regulatory submission support

Tools

SAS

Job description

We are looking for a highly experienced Clinical Statistical Programmer to independently lead programming activities across clinical studies. This role requires deep expertise in SDTM and ADaM dataset development, complex TLF generation, and regulatory submission support.

Key Responsibilities

• Design, develop, and validate SAS programs for SDTM, ADaM, and TLF outputs
• Produce submission‑ready datasets and documentation, including Define.xml
• Review and interpret SAPs and data management plans to determine programming requirements
• Ensure deliverables comply with CDISC and regulatory standards
• Lead programming activities for assigned studies with minimal supervision
• Collaborate with cross‑functional teams and external vendors on data standards and transfers
• Perform quality control and validation of datasets and outputs
• Identify and implement process