Remote Senior Statistical Analyst (SAS, CDISC)

United States Digital Space LLC; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

United States Digital Space LLC is seeking a talented Statistical Analyst to design, implement, and document statistical programs supporting clinical research and regulatory submissions. This contractor role involves independent programming and overseeing CRO activities for an initial one-year term.

The role requires 4+ years in pharmaceutical/biotech statistical programming, extensive SAS use, and strong CDISC SDTM/ADaM familiarity.

Qualifications

• 4+ years hands-on statistical programming experience in pharmaceutical or biotechnology industry.
• SAS used to develop and validate analysis datasets, tables, listings, and figures.
• Experience in regulatory submissions.
• Knowledge of CDISC SDTM/ADaM and FDA/EMA/ICH guidelines.
• Experience working with CROs and overseeing CRO deliverables.
• Strong understanding of clinical trial data structures and statistics.
• Excellent problem-solving, communication, and collaboration skills.
• Ability to manage multiple projects and meet tight deadlines in a fast-paced environment.

Responsibilities

• Plan, develop, validate, and maintain SAS programs for analyses of clinical trial data and generate TLFs for studies and submissions.
• Author and review programming specifications and maintain traceability between source data and outputs.
• Ensure compliance with company standards and regulatory requirements (CDISC SDTM/ADaM).
• Perform quality control checks and validate outputs produced by CROs or other programmers.
• Review SAP and study documentation.
• Engage in other programming activities as required.

Skills

SAS programming

Statistical analysis

CDISC SDTM/ADaM

Regulatory submissions

CRO oversight

Clinical trial data

Education

Master’s degree in Biostatistics/Statistics/Mathematics/CS

Tools

SAS

Job description

United States Digital Space LLC is seeking a talented Statistical Analyst to design, implement, and document statistical programs supporting clinical research and regulatory submissions. This contractor role involves independent programming and overseeing CRO activities for an initial one-year term.

The role requires 4+ years in pharmaceutical/biotech statistical programming, extensive SAS use, and strong CDISC SDTM/ADaM familiarity.