Lead Statistical Programmer

ACL Digital; Bhavnagar; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

ACL Digital is seeking an experienced Statistical Programmer to design and implement SAS-based solutions for regulatory studies in clinical development. The role involves producing CDISC-compliant datasets and outputs for reports, abstracts and manuscripts.

You will write QC programs, create Pinnacle 21 artifacts, and help standardize macros and procedures across projects, while ensuring adherence to GCP/ICH guidelines. Collaboration with Biostatistics and cross-functional teams is essential.

Qualifications

• Masters degree 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 skills and good verbal and written communication skills.
• Ability to work independently.

Responsibilities

• Design or write program specifications based on consultations with Biostats.
• Write SAS codes to produce CDISC compliant datasets.
• Create statistical analysis outputs for reports, abstracts, posters and manuscripts.
• Write QC SAS programs for Dataset, Tables, Listings, and Figures following QC procedures.
• Write programs for ISS, ISE and pooled datasets.
• Revise programs for corrections, enhancements, or system changes.
• Generate Pinnacle 21 reports, Define XML/ PDFs, and Reviewers Guides.
• Assist in establishing standardized programming procedures and work instructions.
• Develop and validate standardized macros and utility programs.
• Ensure regulatory compliance through validation activities.
• Use established standards, SOPs and best practices.

Skills

SAS Base

SAS/STAT

SAS Graph

SAS Macro Language

R programming

Problem solving

Communication

Leadership

Regulatory knowledge (GCP/ICH)

Education

Master's degree in CS or Statistics

Bachelor's degree in CS or Statistics

SAS certification

Tools

SAS

R

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.