Lead Statistical Programmer

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

Job summary

ACL Digital seeks an experienced Statistical Programmer to design and develop SAS-based programs for CDISC SDTM/ADaM datasets and analyses supporting clinical reports and publications.

Candidate should hold a Masters in CS/Statistics (SAS cert preferred), strong Base SAS/SAS/STAT skills, and ability to work independently on regulatory-compliant deliverables within a clinical development context.

Qualifications

• Knowledge of statistics, programming and/or clinical drug development process.
• In-depth knowledge of applicable clinical research regulatory requirements (GCP, ICH).
• Ability to implement programming specifications and estimate scope of work.
• Experience with Base SAS, SAS/STAT, SAS Graph and SAS Macro Language.
• Excellent attention to detail and problem-solving skills.
• Ability to work independently and communicate project status effectively.

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 and manuscripts.
• Write QC SAS programs for Dataset, Tables, Listings, and Figures.
• Write programs for ISS, ISE and pooled datasets and review outputs.
• Generate Pinnacle 21 reports and ensure regulatory compliance.

Skills

Base SAS

SAS/STAT

SAS Graph

SAS Macro Language

CDISC SDTM

CDISC ADaM

GCP

Regulatory knowledge

Communication

Independent work

Education

Masters in CS/Statistics

Bachelor in CS/Statistics

SAS Certification (preferred)

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.