Statistical Programmer

Roles & Responsibilities:

• Develop, program, and validate ADaM datasets as per CDISC standards.
• Create Tables, Listings, and Figures (TLFs) using SAS and/or R.
• Implement Statistical Analysis Plans (SAP) and Statistical Programming Plans (SPP).
• Ensure compliance with regulatory and industry standards (CDISC – SDTM, ADaM).
• Collaborate closely with biostatisticians and clinical teams to ensure data accuracy.
• Develop reusable macros and automate programming processes for efficiency.
• Perform independent QC checks on statistical outputs and deliverables.
• Support programming activities across multiple therapeutic areas including Oncology, Neuroscience, and Immunology.

Qualifications
• Graduate / Postgraduate in Life Sciences, Engineering, Statistics, or related disciplines.

Experience:

• 3 to 12 years of experience in clinical or biostatistical programming.
• Hands-on experience in ADaM, TLF development, and clinical trial data analysis.

Skills:

• Strong expertise in SAS and/or R programming.
• In-depth knowledge of CDISC standards (SDTM, ADaM).
• Experience working with clinical trial protocols and regulatory guidelines.
• Proficiency in TLF generation and data manipulation techniques.
• Strong analytical, problem-solving, and attention-to-detail skills.

• Exposure to additional tools such as Python or SQL (preferred).
• Basic understanding of machine learning concepts applied to clinical data (preferred).

About the Organisation:

The organization is a leading clinical research and data analytics-driven company supporting global clinical trials across multiple therapeutic areas, offering a collaborative work environment, exposure to regulatory-compliant projects, and long-term career growth opportunities in statistical and clinical programming.