Job Description

Dear,

Hope you are doing well.

Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to manju@nam-it.com

Note : NO 3 rd party candidates, or H1's/EAD's/OPT's please.

Role :Statistical Programmer II

Location :Remote

Duration : 6+ months contract

EST ZONE CANDIDATES ONLY

Statistical Programming II:

Key responsibilities

1. At least 5 years of experience in ADaM/TLF.
2. Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverables
3. Develop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.
4. Collaborate with statisticians and data managers to define dataset specifications and outputs
5. Ensure compliance with internal SOPs, CDISC standards, and regulatory requirements
6. Conduct quality control checks and peer reviews of programming code and study outputs
7. Support submission activities including eCTD and regulatory responses as needed
8. Document programming activities and maintain clear audit trails
9. Has experience on the safety ADaM/TLF production side instead of validation side
10. Has experience leading pivotal studies (phase 2, phase 3 studies).
11. Strong proficiency in SAS programming (Base, Macro, SQL); familiarity with R or Python is a plus
12. Develop study protocols, statistical analysis plans (SAPs), and define analysis datasets
13. Understanding of CDISC standards (SDTM, ADaM)
14. Knowledge of FDA/EMA regulatory requirements and e-submission standards
15. Excellent problem-solving and communication skills
16. Experience with oncology, rare diseases, or global trials
17. Exposure to automation tools or advanced data visualization techniques
18. Ability to mentor junior programmers or lead small projects

Manjunath

Staffing Manager

Nam Info Inc

Ph:732-993-5319 / Email:manju@nam-it.com

Website:

Address: 2525 US Highway 130, Bldg D, Suite2 Cranbury, NJ-08512

USA | CANADA | INDIA

MBE Certified Company , E Verify Company

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