9am - 5:30pm CST including 30 mins lunch break, Monday to Friday
Can be fully remote, or hybrid in Lake County / SFO/NJ site. The laptop can only be used in the US. Working oversea is not allowed in any situation.
Responsibilities:
Complete assignments from Client lead programmers on time and with good quality; provide updates to study lead programmer and peer programmers as needed. ADaM programming and validation, TFL programming and validation, additional quality review of statistical programing deliverables; communicate with programming team on issues of various types.
• 5+ yrs of experience in Statistical Programming using SAS preferably in UNIX environment, supporting clinical trials data analysis. Enterprise Guide experience is a plus.
• Solid CDISC Standards knowledge, and solid ADaM programming experience including both safety and efficacy analyzes. Oncology TA experience is preferred.
• Experienced in supporting ISS, Client ADaM programming and submissions is a plus.
• Ability to quickly learn internal macros, processes and interpret Pinnacle 21 results.
• Team player with excellent communication skills and experience working with stat programmers, statisticians and data management personnel.
Top 5 skills/requirements this person is required
1. Dataset and TLF generation and validation for clinical trials using SAS
2. CDISC knowledge, familiarity with ADaMIG, ADaM specification experience
3. understand study documents and common safety and efficacy analyses
4. teamwork, effective communication
5. oncology Therapeutic Area experience or knowledge
6. regulatory submission experience or knowledge
Years of experience, education, and/or certification is required