Lead Statistical Programmer

Humaneva Group

. Produce and coordinate SAS programs, outputs, and study reports for clinical trial programs .

Posted 10/1/2026full-timeRemote • IndiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in SAS Programming for clinical trials, ensuring compliance with CDISC Data Standards and ICH-GCP Regulatory guidelines. Capable of leading programming teams, performing quality control, and mentoring associates while maintaining high standards of accuracy and efficiency.

Highest-signal resume keywords

SAS ProgrammingCDISC Data StandardsICH-GCP Regulatory GuidelinesClinical Trial MethodologiesStatistical Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS ProgrammingStatistical ProgrammingData ValidationQuality ControlStatistical AnalysisData CleaningProgramming for IntegrationDefine.xml CreationClinical Data AnalysisReconciliation of External Data

Soft Skills

Excellent Communication SkillsMentoringTeam LeadershipProcess ImprovementFeedback Provision

Tools & Technologies

SASMacrosTemplatesUtilities

Industry Keywords

Clinical TrialsGood Clinical PracticesRegulatory Agency RequirementsTherapeutic AreasMedical Terminology

About the role

Key responsibilities & impact

Produce and coordinate SAS programs, outputs, and study reports for clinical trial programs
Independently perform quality control on statistical outputs to achieve First Time Right outputs
Function as study lead programmer and/or subject matter expert for complex studies
Lead project assignments and programming teams as point of contact with Project Management and sponsor teams
Maintain compliance with ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and company procedures
Participate in project kick-off meetings to understand scope, plans, timelines, and project-specific requirements
Develop and/or validate CDISC Data Standards specifications and programming for moderate-complex studies
Develop and/or validate programming for integration of databases from multiple studies and sources
Develop, validate, and document statistical programs for tables, figures, and listings
Create or review Define packages (Define.xml) and Reviewer Guides for CDISC Data Standards
Maintain, verify, and ensure quality and accuracy of assigned tasks
Complete client-specific and organization-specific training documentation on time
Forecast team workload and provide vision and clarity on project objectives, milestones, and upcoming projects
Assist with SAS programs, macros, templates, and utilities for data cleaning and reporting
Perform reconciliation of external data
Provide advanced technical expertise with minimal supervision for clinical data analysis and reporting
Mentor associates and support training for trainees and team members
Provide process-improvement inputs to increase efficiency and align processes with regulatory and industry requirements
Periodically evaluate team members and provide feedback
Support internal or external audit requirements and quality/process improvement initiatives
Perform other duties assigned by the Department Head or Immediate Supervisor

Requirements

What you’ll need

Any bachelor’s or master's degree, preferably in computer science, engineering, mathematics, statistics or life science
Minimum 8-10 years of relevant SAS programming experience for all clinical trial phases
Ability to independently perform SAS programming
Good working knowledge in all phases of clinical trials
Exposure in working in various therapeutic areas
Proficiency in clinical industry standards, CDISC Data standards, ICH-GCP Regulatory guidelines, medical terminology and clinical trial methodologies
Excellent verbal and written communication skills

Benefits

Comp & perks

Employee position
Remote work arrangement