Senior Statistical Programmer (Oncology)

ACL Digital; Pennsylvania; Remote; USD 130,000 - 180,000; Full time

Job summary

ACL Digital is seeking a Senior Statistical Programmer with 9–12 years of clinical trial programming experience to lead SDTM/ADaM coding for oncology studies across Phases I–IV on a 100% remote US-based contract.

The role requires direct sponsor/BioPharma exposure, expert CDISC knowledge, and advanced SAS (Base, STAT, GRAPH, MACRO). You will develop reusable macros, perform QC, and prepare submission-ready datasets and documentation for FDA/EMA regulatory packages.

Qualifications

• 9–12 years of progressive SAS statistical programming experience in Pharma/biotech/CRO.
• Direct sponsor/BioPharma experience within a sponsor organization.
• At least 4+ years of hands-on oncology clinical trials.
• Expert knowledge of CDISC standards (SDTM/ADaM, define.xml, Pinnacle 21).
• Experience preparing submission packages for FDA/EMA approvals (eCTD Module 5).

Responsibilities

• Lead end-to-end SDTM/ADaM design, development, execution, and validation.
• Write complex SAS code to generate Tables, Listings, and Figures for safety and efficacy analyses.
• Develop reusable SAS macros to improve efficiency and consistency.
• Perform independent QC double-programming for key deliverables and ensure data traceability.
• Collaborate with Biostatisticians to review SAPs and TLF shells.

Skills

SAS programming

Oncology domain

CDISC SDTM/ADaM

R for reporting

Education

Bachelor's or Master's in Statistics/CS/Math/Life Sciences

Tools

SAS

R

Pinnacle 21

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

• 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.

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.