Biostatistician

Airvin Skills; Hyderabad, Chennai, Bengaluru; Hybrid; INR 600,000 - 1,000,000; Full time

Job summary

Airvin Skills is seeking a Clinical SAS Programmer to develop and validate clinical trial datasets using Base SAS, SAS Macros, and SAS SQL. You will generate comprehensive Tables, Listings, and Figures to support CSR activities and biostatistics teams.

The role requires strong experience with CDISC SDTM/ADaM standards, ED C data handling, and rigorous data quality controls, ensuring adherence to ICH, GCP, and FDA 21 CFR Part 11 guidelines.

Qualifications

• Proficient in SAS programming for clinical data management.
• Experience with CDISC SDTM/ADaM standards.
• Familiarity with validation of SDTM/ADaM datasets.

Responsibilities

• Develop, validate, and maintain clinical trial datasets using Base SAS, SAS Macros, and SAS SQL.
• Generate Tables, Listings, and Figures to support CSR and biostatistics teams.
• Ensure compliance with CDISC standards, focusing on SDTM and ADaM datasets creation and validation.
• Perform ETL on raw clinical data from various EDC platforms.
• Write and execute code to generate Edit Checks, resolve data discrepancies, and implement data quality controls.
• Use SAS ODS and procedures like Proc SQL, Proc Freq, and Proc Means for reporting.
• Maintain compliance with ICH, GCP, and FDA 21 CFR Part 11.

Skills

SAS programming

Data management

Biostatistics

EDC data handling

Education

Master's in Biostatistics / Life Sciences

Tools

Base SAS

SAS Macros

SAS SQL

ODS

Job description

Role & responsibilities

• Develop, validate, and maintain clinical trial datasets using Base SAS, SAS Macros, and SAS SQL.
• Generate highly accurate TLFs (Tables, Listings, and Figures) to support Clinical Study Reports (CSR) and biostatistics teams.
• Ensure strict compliance with CDISC standards, specifically focusing on the creation and validation of SDTM and ADaM datasets.
• Perform ETL (Extract, Transform, Load) activities on raw clinical data imported from various EDC (Electronic Data Capture) platforms.
• Write and execute code to generate Edit Checks, resolve data discrepancies, and implement robust data quality control procedures.
• Utilize SAS ODS and procedures like Proc SQL, Proc Freq, and Proc Means for custom reporting.
• Maintain compliance with regulatory guidelines including ICH, GCP, and FDA 21 CFR Part 11.

Preferred candidate profile

• Masters or Bachelor's degree in Biostatistics, Bioinformatics, Biotechnology, Pharmacy (B.Pharm/M.Pharm), or Life Sciences.
• Basic understanding or certification in Clinical SAS Programming, CDISC, SDTM, or ADaM standards.
• Strong analytical mindset with a keen interest in Clinical Data Management (CDM) and biostatistical analysis.
• Excellent problem-solving skills and the ability to work collaboratively in cross-functional clinical trial teams.