[Remote] Clinical Statistical Programmer - III (Senior)

Note: The job is a remote job and is open to candidates in USA. Net2Source is a global workforce solutions company connecting professionals with employment opportunities. The Senior Clinical Statistical Programmer will provide expert statistical programming support for clinical and device studies, regulatory submissions, exploratory analyses, and publications. The role will also develop and validate SAS programs and macros, perform quality control, and collaborate with biostatistics, data management, and cross-functional teams.

Responsibilities

• Provide expert-level hands-on support for all internal statistical programming needs for clinical, device studies including but not limited to CSR, ISS and Client summaries and exploratory data analyses
• Perform rigorous quality control (QC) of programming deliverables to ensure accuracy and compliance with regulatory standards
• Collaborate closely with biostatistics, data management, and cross-functional teams to support ongoing clinical trials, FDA submissions, publications, and other business needs
• Develop, validate, and maintain departmental standard macros and template programs
• Write and validate SAS programs to generate SDTM, ADaM datasets, and TLFs (Tables, Listings, and Figures)
• Write, review, and approve data specifications for SDTM and ADaM datasets
• Contribute to the development and implementation of innovative programming strategies and tools
• Ensure adherence to departmental SOPs, guidelines, and regulatory requirements

Skills

• • Minimum of 10+ years of hands-on statistical programming experience in the pharmaceutical, biotech, or CRO industry
• • Advanced knowledge of GCP/ICH guidelines and FDA regulatory requirements; prior experience with NDA/MAA/BLA submissions is preferred
• • Strong expertise in SAS programming and macro development; experience with R or Python is a plus
• • In-depth knowledge of CDISC standards including SDTM, ADaM, Define.xml, and submission-ready datasets
• • Demonstrated ability to manage multiple projects and shifting priorities in a fast-paced environment
• • Excellent written and verbal communication skills
• • Expert level proficiency in SAS programming and experience in CDISC SDTM/ADaM and submission standards
• • Expert level ability to write efficient, reusable macros and provide innovative programming solutions
• • Strong project management skills with the ability to prioritize tasks and meet tight deadlines while maintaining high quality
• • Familiarity with programming in R or Python for statistical analysis or automation is highly desirable
• • Experience supporting regulatory submissions and publication requests

Benefits

• Remote work arrangement
• Work-life balance
• Professional growth
• Leadership opportunities at all levels
• Collaborative culture

Company Overview

Net2Source (N2S) is a Minority owned global workforce solutions company recognized by SIA as the largest and fastest-growing Total Talent Solutions provider with a presence in 34 countries and in-house Glo-Cal (global and local) teams to support our clients. It was founded in 2007, and is headquartered in Somerset, New Jersey, USA, with a workforce of 1001-5000 employees. Its website is http://net2source.com.

Company H1B Sponsorship

Net2Source (N2S) has a track record of offering H1B sponsorships, with 3 in 2025, 7 in 2024, 8 in 2022, 10 in 2021, 25 in 2020. Please note that this does not guarantee sponsorship for this specific role.