16 Aug
|
Teamware Solutions
|
India
16 Aug
Teamware Solutions
India
Role:
Statistical Programmer
Experience:
4–10 years
Locations:
Hyderabad, Bangalore, Chennai, Pune, Mumbai, Kochi, Delhi, Kolkata
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.
- Valuable 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 10 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