Lead Statistical Programmer

ACL Digital; India; On-site; INR 800,000 - 1,200,000; Full time

Job summary

ACL Digital is seeking a skilled Statistical Programmer to develop and maintain programming solutions for client projects in the pharmaceutical sector. The role requires deep SAS expertise, CDISC SDTM/ADaM knowledge, and a strong grasp of regulatory guidelines.

You will design specifications, write complex SAS code, and produce datasets, tables, listings, and figures for final reports and publications. Collaboration with Biostatistics and QA teams is essential for success.

Qualifications

• Masters in computer science, statistics, or related field.
• SAS certification preferred but not mandatory.
• CDISC SDTM/ADaM knowledge beneficial.
• Strong understanding of GCP and regulatory guidelines.

Responsibilities

• Develop and maintain programs to meet client needs.
• Plan and lead development of project-related statistical programming tasks.
• Write SAS code for SDTM/ADaM datasets and outputs.
• Create and validate statistical outputs for reports, abstracts, and manuscripts.
• Generate Pinnacle 21 reports and Define-XML/ PDFs as required.
• Establish standardized programming procedures and macros.

Skills

Statistics & programming

GCP & ICH knowledge

Leadership & communication

Regulatory compliance awareness

Education

Master's degree in computer science or statistics

Bachelor's degree in computer science or statistics

CDISC SDTM & ADaM knowledge

Tools

Base SAS

SAS/STAT

SAS Graph

SAS Macro Language

Pinnacle 21

Job description

Roles and Responsibilities:

• 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.
• 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.