Role: Statistical Programmer

Experience: 6–10+ years

Locations: Remote

Notice Period: Immediately to 15 days

Minimum Requirements:

- Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, or Life Sciences.
- At least 8 years of programming experience in the clinical industry recommended.
- Demonstrated proficiency in analytical programming.
- In-depth understanding of clinical data structures, including CDISC standards and relational databases.
- Experience with software tools and applications such as MS Office, XML, and Pinnacle 21.
- Experience handling and processing upstream data, including multiple data forms, workflow, eDC, and SDTM.
- Experience providing outputs to meet downstream requirements, including ADaM, Data Definition Table, and e-submission.
- Good understanding of regulatory, industry,



and technology standards and requirements.
- Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
- Ability to work effectively in a team setting with clinical team members.

Preferred Requirements:

- Minimum of 6 years of clinical/statistical programming experience within pharmaceutical clinical development, including support for regulatory filings such as NDA, BLA, and MAA.
- Knowledge of the drug development process, clinical trial methodology, statistics, and global regulatory requirements.
- Experience with other software packages such as R.
- Experience with the Linux operating system.

📌 Statistical Programmer (India)
🏢 Teamware Solutions
📍 India