Lead Statistical Programmer

ACL Digital; Tiruppur; On-site; INR 900,000 - 1,300,000; Full time

Job summary

ACL Digital is seeking a skilled SAS Programmer to design and maintain SDTM/ADaM datasets and generate analysis outputs for regulatory submissions. You will develop QC processes, build macros, and ensure adherence to GCP/ICH guidelines.

Role requires strong Base SAS knowledge, experience with Pinnacle 21, Define XML, and ability to work independently within a clinical programming team in India. Masters in CS or Statistics preferred.

Qualifications

• Knowledge of statistics, programming and clinical drug development process.
• In-depth knowledge of GCP and ICH guidelines.
• Ability to implement programming specifications.
• Estimate programming scope of work and communicate project status.
• Working knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language.
• Problem solving with attention to detail.
• Strong organizational, verbal and written communication.

Responsibilities

• Design or write program specifications from Biostats consultations.
• Write SAS codes to produce CDISC compliant datasets.
• Create statistical analysis outputs for reports, abstracts and posters.
• Write QC SAS programs for Datasets, Tables, Listings, and Figures.
• Develop programs for ISS/ISE and pooled datasets.
• Revise programs for corrections or environment changes.
• Generate Pinnacle 21 reports, Define XML, and Review Defined PDFs.
• Establish standardized programming procedures and work instructions.
• Develop and validate standardized macros and utilities.
• Ensure regulatory requirements through validation/compliance activities.

Skills

Base SAS

SAS/STAT

SAS Graph

SAS Macro Language

CDISC SDTM/ADaM

GCP/ICH guidelines

R programming (preferred)

Pinnacle 21

Define XML

Problem solving

Education

Masters in CS/Statistics

Bachelor in CS/Statistics

CDISC SDTM/ADaM knowledge

SAS certification (preferred)

R programming knowledge (preferred)

Tools

Pinnacle 21

Define XML

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

Excellent organizational skills and good verbal and written communication skills.

Ability to work independently.

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.