Lead Statistical Programmer

ACL Digital; Chhatrapati Sambhajinagar District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

ACL Digital in India seeks an experienced Statistical Programmer to develop and maintain SAS programs for CDISC-compliant datasets and outputs. You will create analyses for reports, posters, and manuscripts, write QC processes, and generate Pinnacle 21 and Define XML/ PDFs.

Collaboration with Biostatistics and other teams is essential. The role requires strong SAS expertise, knowledge of GCP, and the ability to manage multiple tasks with accuracy and clear communication.

Qualifications

• Masters or higher in computer science, statistics, or related field.
• SAS certification preferred but not required.
• R programming knowledge preferred but not required.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Good understanding of GCP regulatory requirements and drug development process.
• Excellent organizational and communication skills.

Responsibilities

• Design or write program specifications based on consultations with Biostats.
• Write SAS codes to produce CDISC compliant datasets.
• Create statistical analysis outputs for final reports, abstracts, posters, manuscripts, adhocs, and other publications.
• Write QC SAS programs for Dataset, Tables, Listings, and Figures following QC procedures and best practices.
• Develop programs for ISS, ISE and pooled datasets.
• Revise programs for corrections, enhancements, or environment changes.
• Generate Pinnacle 21 reports, Define XML/Define PDFs, and Reviewers Guides; fix errors/warnings.
• Assist in establishing standardized programming procedures and work instructions.
• Develop and validate standardized macros and utility programs.
• Ensure regulatory requirements are met through validation/compliance activities.
• Promote use of established standards, SOPs and best practices.
• Other responsibilities as assigned.

Skills

Base SAS

SAS/STAT

SAS Graph

SAS Macro Language

CDISC SDTM/ADaM

Clinical programming

GCP knowledge

Problem solving

Communication skills

Education

Masters in computer science/statistics or related field

Bachelors in computer science/statistics

Tools

Pinnacle 21

Job description

Purpose:

• Provide advanced technical expertise to develop and maintain programs/methodology to meet internal and external clientele needs.
• Plan and lead the development of project-related solutions to the full scope of statistical programming tasks.
• Provide technical expertise to the Statistical Programming department.

Roles and Responsibilities:

• Design or write program specifications based on consultations with Biostats
• Write SAS codes to produce CDISC complaint datasets.
• Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts, adhocs and other clinical publications.
• Write QC SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures and good programming practices.
• Write programs for ISS, ISE and pooled datasets.
• Revise programs for corrections, enhancements, or system environment changes.
• Generate Pinnacle 21 reports, Define XML, Define PDFs, and Reviewers Guides. Review Pinnacle 21 report for action needed to fix errors and warnings.
• Assist in establishing standardized programming procedures and work instructions.
• Develop, enhance, evaluate, and validate standardized macros and utility programs.
• Ensure that regulatory requirements are met through validation/compliance activities.
• Use and promote use of established standards, SOP and best practices.
• Other responsibilities as assigned.

Required Knowledge, Skills and Abilities:

• Knowledge of statistics, programming and/or clinical drug development process
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Ability to implement programming specifications, as appropriate
• Ability to estimate programming scope of work and assist in communicating project status
• Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
• Exhibits routine and occasionally complex problem-solving skills
• Recognizes when negotiating skills are needed and seeks assistance.
• Good organizational, interpersonal, leadership and communication skills
• Ability to effectively handle multiple tasks and projects, under supervision
• Excellent accuracy and attention to detail
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients

Minimum Education and Experience:

• Masters degree in computer science, statistics or related field; Bachelor's degree in computer science, statistics or equivalent combination of education, training and experience.
• SAS certification preferred but not required.
• R programming knowledge preferred but not required.
• Strong knowledge of CDISC SDTM and ADaM standards.
• Good understanding of GCP regulatory requirements and drug development process.
• Excellent organizational skills and good verbal and written communication skills.
• Ability to work independently.