Statistical Programmer

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 environment 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.