Senior Statistical Programmer; Oncology

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

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.

• 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.
• 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.
• 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.
• 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.

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 / Bio Pharma 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.

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.