Lead Clinical Statistical Programmer

Company

REV Clinical (formerly CBCC Global Research)

Position

Lead Clinical SAS Programmer

Function

Clinical Statistical Programming / Biometrics

Location

Remote

Website

www.revclinical.com

COMPANY BACKGROUND

REV Clinical (formerly CBCC Global Research), headquartered in Bakersfield, California with additional operations in Ahmedabad, India, is a leading, multi-national clinical contract research organization with deep experience in designing and managing clinical trials across a range of therapeutic areas, including Oncology, CNS, and Ophthalmology. REV Clinical provides end-to-end CRO services spanning clinical study design, project management, data analysis, regulatory strategy and medical writing — across Phase I–IV clinical trials for leading biopharmaceutical companies.

ROLE: Lead Clinical SAS Programmer

We are seeking an experienced Lead Clinical SAS Programmer to support global clinical development programs and regulatory submissions. The ideal candidate will have strong expertise in SAS programming, CDISC SDTM and ADaM standards, clinical trial analysis, and the development and validation of Tables, Listings, and Figures (TLFs), along with prior experience supporting global clinical trials, including oncology studies, and collaborating with US-based CROs, sponsors, biostatisticians, and cross-functional clinical development teams. The role requires the ability to independently manage study-level programming deliverables, provide technical guidance to programming team members, and deliver high-quality clinical datasets and reports in accordance with study specifications, SOPs, regulatory requirements, and agreed timelines.

KEY RESPONSIBILITIES

Clinical SAS Programming & Technical Leadership

• Lead and independently execute clinical statistical programming activities for assigned studies, ensuring timely delivery, accuracy, quality, and compliance with project requirements
• Develop, maintain, and optimize SAS programs using Base SAS, DATA steps, PROC SQL, macros, and other relevant SAS procedures
• Develop reusable SAS macros, programming templates, utilities, and standardized solutions for clinical data processing, analysis, and reporting
• Build, transform, derive, and reconcile clinical datasets from clinical databases, source datasets, and external data transfers
• Troubleshoot complex programming issues, investigate SAS log errors and warnings, and optimize program performance
• Review programming specifications, provide technical guidance, conduct code reviews, and support junior programmers
• Ensure consistent implementation of programming standards, reusable code, naming conventions, and documentation practices across assigned studies

SDTM, ADaM & Regulatory Submission Deliverables

• Develop, maintain, and validate CDISC-compliant SDTM and ADaM datasets in accordance with applicable standards, study specifications, and regulatory requirements
• Program standard and study-specific SDTM domains and ADaM datasets, including ADSL and analysis datasets based on study design
• Implement analysis derivations, treatment variables, population flags, baseline definitions, visit windows, analysis parameters, and other study-specific requirements
• Maintain traceability from source data through SDTM and ADaM datasets to final analysis outputs
• Prepare, review, or support development of define.xml, dataset specifications, metadata, and other required submission documentation
• Review and resolve applicable Pinnacle 21 validation findings and CDISC conformance issues
• Ensure deliverables are submission-ready and comply with sponsor standards, company SOPs, and health authority requirements

TLF Development, Statistical Analysis & Reporting

• Develop, program, review, and validate TLFs in accordance with the protocol, Statistical Analysis Plan (SAP), mock shells, and approved programming specifications
• Program safety and efficacy outputs, including demographic summaries, subject disposition, adverse event summaries, laboratory analyses, concomitant medication listings, and efficacy endpoints
• Support oncology-specific analyses, as applicable, including tumor response assessments, response rates, progression-free survival (PFS), overall survival (OS), and other time-to-event endpoints
• Support pharmacokinetic (PK) data processing and reporting for applicable studies
• Collaborate with biostatisticians to clarify statistical methods, analysis populations, derivations, and reporting requirements
• Support preparation of clinical study reports and statistical summary documentation by providing validated datasets, tables, listings, figures, and programming inputs
• Ensure consistency between analysis datasets, statistical outputs, table shells, and reporting specifications

Quality Control & Independent Validation

• Develop and execute appropriate QC and validation strategies for clinical datasets, SAS programs, TLFs, and other programming deliverables
• Perform independent programming, code review, output comparison, reconciliation, and other validation activities per project requirements
• Review SAS logs, investigate discrepancies, document findings, and ensure timely resolution of issues
• Verify that analysis datasets and outputs conform to the SAP, programming specifications, study standards, and regulatory expectations
• Maintain complete and accurate programming documentation, QC evidence, version history, and audit-ready records
• Ensure final deliverables meet established quality standards and are appropriately reviewed before release or submission

Global Trial & Oncology Study Support

• Support global clinical trials across Phase I–IV development programs, depending on assigned study requirements
• Apply understanding of clinical development, study protocols, data structures, statistical analysis requirements, and regulatory reporting processes
• Support oncology clinical trials with familiarity in oncology-specific endpoints, tumor assessment data, response criteria, and time-to-event analyses
• Collaborate with US-based CROs, global sponsor teams, biostatisticians, clinical data management teams, and other cross-functional stakeholders
• Participate in global project meetings, specification discussions, study status reviews, and issue-resolution activities
• Review clinical data transfers and ongoing study data to identify data quality concerns and potential impacts on analysis or reporting, escalating to appropriate teams

Cross-Functional Collaboration & Study Management

• Work closely with Biostatistics, Clinical Data Management, and other project stakeholders to clarify requirements and resolve data and programming issues
• Provide technical input into SAPs, mock shells, programming specifications, annotated CRFs, and related study documentation
• Review CRF annotations and data specifications for consistency with planned analyses and programming requirements
• Collaborate with Clinical Data Management on data validation requirements, edit checks, data review, and data cleaning activities, as applicable
• Communicate study progress, programming risks, dependencies, and potential delays to programming leads, statistics leads, and project stakeholders
• Track milestones, manage assigned deliverables, and proactively address issues affecting study timelines or submission readiness
• Maintain complete records and archive programming deliverables, datasets, outputs, specifications, and documentation per company procedures
• Contribute to process improvements, programming standards, knowledge sharing, and technical mentoring
• Perform other relevant responsibilities as assigned by the reporting manager or management

QUALIFICATIONS

• Bachelor's or master's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related discipline
• Minimum 8 years of experience in the pharmaceutical, biotech, or CRO industry, including approximately 6 years of hands-on clinical statistical programming
• Strong proficiency in Base SAS, DATA step programming, PROC SQL, SAS macros, data manipulation, debugging, and program optimization
• Proven experience developing, validating, and maintaining CDISC-compliant SDTM and ADaM datasets
• Strong experience programming and validating clinical trial TLFs for safety and efficacy reporting
• Experience supporting global clinical trials, including oncology studies, and collaborating with US-based CROs and sponsors

SKILLS/ABILITIES

• Ability to independently manage study-level programming deliverables and provide technical guidance to team members
• Strong analytical, debugging, and problem-solving skills
• Strong attention to detail with a commitment to quality, traceability, and audit-ready documentation
• Effective written and verbal communication skills for working with global, cross-functional teams
• Ability to manage multiple deliverables and timelines, proactively flagging risks and dependencies
• Knowledge of ICH-GCP, SOP compliance, and regulatory submission requirements

COMPENSATION

An attractive compensation package commensurate with experience and this senior role will be provided.