Senior Statistical Programmer

Role: Senior Statistical Programmer

Employment Type: Long-Term Contract (ACL Digital W2) (No C2C)

Location: 100% Remote (US-based)

Experience Level: 9 to 12 Years

Domain Requirement: Deep Therapeutic Experience in Oncology

Sponsor Requirement: Direct Sponsor / In-House Biopharma Experience Required

About the Role

ACL Digital is seeking an experienced, highly autonomous Senior Statistical Programmer with 9 to 12 years of clinical trial programming expertise to join our life sciences practice on a long-term contract basis.

In this role, you will work closely with biostatistics, data management, and clinical teams to lead and execute statistical programming deliverables across Phase I–IV clinical trials, with a primary focus on Oncology . The ideal candidate must have direct experience working inside a Sponsor / Pharmaceutical organization environment and demonstrate an advanced command of CDISC standards, complex SAS programming, and global regulatory submission packages.

Key Responsibilities

1. Statistical Programming & Technical Leadership

• Lead the end-to-end design, development, execution, and validation of SDTM and ADaM datasets following CDISC standards and study specifications.
• Write complex, production-quality SAS code to generate Tables, Listings, and Figures (TLFs) for safety and efficacy analysis.
• Develop and maintain standardized, reusable SAS macros to optimize team efficiency and maintain programming consistency across studies.
• Perform independent quality control (QC) double-programming for critical study deliverables, ensuring 100% data traceability and compliance.

2. Oncology Domain Expertise

• Apply deep clinical domain knowledge to program complex oncology endpoints (e.g., Progression-Free Survival (PFS), Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DoR), RECIST 1.1, and iRECIST criteria).
• Analyze and report on complex oncology trial structures, including dose-escalation, basket, umbrella, and combination therapy designs across solid tumors and hematologic malignancies.

3. Regulatory Submissions & Sponsor Oversight

• Prepare electronic submission deliverables for regulatory bodies (FDA, EMA, PMDA), including define.xml, Analysis Data Model Reviewer's Guides (ADRG), SDTM Reviewer's Guides (SDRG), and Analysis Results Metadata (ARM).
• Program and validate pooled analysis datasets for Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE).
• Support sponsor responses to regulatory agency requests, ad-hoc queries, and post-hoc analyses.

4. Cross-Functional Collaboration

• Serve as the primary statistical programming point of contact for assigned clinical studies.
• Partner directly with Biostatisticians to review Statistical Analysis Plans (SAPs) and TLF shells for operational and programming feasibility.
• Collaborate with Data Management and Clinical Operations to resolve complex data discrepancies and protocol deviations.

Technical & Functional Requirements

Requirement Details

Experience

9 to 12 years of progressive SAS statistical programming experience in Pharma, Biotech, or CRO environments.

Sponsor Experience

Mandatory: Direct experience working within a Sponsor / BioPharma company environment (handling in-house submission pipelines and internal stakeholder communication).

Therapeutic Specialty

Mandatory: At least 4+ years of dedicated hands-on experience in Oncology clinical trials .

Language Proficiency

Advanced SAS (Base SAS, SAS/STAT, SAS/GRAPH, SAS/MACRO). Hands-on experience with R for statistical reporting or open-source submission workflows is a strong plus.

CDISC Standards

Expert knowledge of CDISC standards (SDTM , ADaM implementation , Define.xml , Pinnacle 21 validation tools).

Submissions

Direct experience preparing submission packages for FDA/EMA approvals (Phase II/III, eCTD Module 5).

Education

Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related quantitative field.

Contract & Compliance Conditions

• Engagement Model: ACL Digital W2 (Contract / Consultant)
• Location: 100% Remote (US-based)
• Duration: Long-Term Contract
• Reference Check: Mandatory Professional Work References required. Candidates must be able to provide contact details for 2–3 supervisory references (e.g., Lead Statistici