Job Description

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 Statistician, Functional Manager, or Sponsor Lead) upon request.

Interested candidates, send your updated resume to karthik.s@acldigital.com along with the references.

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