Statistical Programmer

Latinum HR Solutions; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Latinum HR Solutions in Bengaluru, India, seeks an experienced SAS Programmer to develop and validate SDTM, ADaM, and TFLs, and to support regulatory submissions for global clinical studies.

You will review protocols and annotated CRFs, perform QC on SAS programs, and collaborate with Biostatistics and CDISC teams to ensure compliance with FDA/ICH guidelines. Strong knowledge of SDTM/ADaM, Define.xml, and Pinnacle 21 is preferred.

Qualifications

• Experience with SDTM, ADaM, CDISC, TFL Programming, and Define.xml.
• Knowledge of FDA/ICH regulatory guidelines.
• Experience working on Phase I–IV clinical studies.

Responsibilities

• Develop and validate SDTM, ADaM, and TFLs.
• QC and validation of SAS programs and datasets.
• Support regulatory submissions for global clinical studies.
• Collaborate with Biostatistics, CDM, and cross-functional teams.

Skills

Strong experience in Base SAS

SAS Macros

SQL

Analytical and communication skills

Tools

Pinnacle 21

Job description

• Develop and validate SDTM, ADaM, and TFLs using Base SAS and SAS Macros.
• Perform statistical programming activities in compliance with CDISC standards.
• Create and maintain Tables, Listings, and Figures (TFLs) based on Statistical Analysis Plans (SAPs).
• Review protocols, Annotated CRFs, and specifications to develop submission-ready datasets.
• Perform QC and validation of SAS programs and datasets.
• Support regulatory submissions for global clinical studies.
• Collaborate with Biostatistics, Clinical Data Management, and cross-functional teams.

Required Skills :

• Strong experience in Base SAS, SAS Macros, and SQL.
• Hands-on experience with SDTM, ADaM, CDISC, TFL Programming, and Define.xml.
• Good understanding of FDA/ICH regulatory guidelines.
• Experience working on Phase I-IV clinical studies.
• Excellent analytical, problem-solving, and communication skills.

Preferred

• Experience across therapeutic areas such as Oncology, Diabetes, Cardiovascular, or Immunology.
• Exposure to Pinnacle 21 and submission support will be an added advantage.