Statistical Programmer

Jobtailor; Pune District; On-site; INR 1,100,000 - 1,700,000; Full time

Job summary

Jobtailor in Pune is seeking a Senior Statistical Programmer to develop custom SAS code for tables, listings, graphs, and derived datasets in support of clinical trial analyses.

You will validate programming outputs, ensure quality, mentor junior programmers, and coordinate with biostatisticians and project teams while adhering to ICH guidelines and SOPs. Strong communication and project-management skills are essential.

Qualifications

• Undergraduate degree in a scientific or statistical discipline.
• In lieu of a degree, an equivalent combination of education and programming experience.
• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
• Excellent written and verbal communication skills.
• Ability to read, write, speak and understand English.
• Knowledge of SOPs, work instructions and regulatory guidelines such as ICH.

Responsibilities

• Develop custom programming code using SAS to generate summary tables, data listings, graphs and derived datasets per SAPs.
• Ensure outputs meet quality standards and project requirements.
• Perform validation programming and resolve discrepancies with Programmers, Biostatisticians and project team members.
• Keep project team members informed of programming progress and issues.
• Follow SOPs, WIs and regulatory guidelines such as ICH.
• Maintain complete project documentation and QC documents and programs.
• Manage schedules and time constraints across multiple projects and adapt workload to changing priorities.
• Anticipate and address programming issues to support efficient programming and review.
• Mentor programming personnel through training, work review, feedback and process guidance.
• Transfer deliverables and perform other assigned work-related duties.

Skills

SAS Programming

Statistical Analysis Plans

Clinical Trial Experience

Regulatory Guidelines (ICH)

Project Management

Education

Undergraduate degree in scientific/statistical discipline

Equivalent combination of education and programming experience

Tools

Custom Programming Code Development

Validation Programming

Data Listings Generation

Graph Creation

Derived Datasets Creation

Quality Control

Dataset Specifications Development

Programming Specifications Review

Statistical Programming Leadership

Documentation Maintenance

Job description

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs and derived datasets according to statistical analysis plans and programming specifications


• Ensure outputs meet quality standards and project requirements


• Perform validation programming and resolve discrepancies with Programmers, Biostatisticians and project team members


• Keep project team members informed of programming progress and issues


• Follow applicable SOPs, WIs and relevant regulatory guidelines such as ICH


• Maintain complete, current project documentation, testing, verification and quality-control documents and programs


• Manage schedules and time constraints across multiple projects and adapt workload to changing priorities


• Develop specifications for datasets and outputs of any complexity


• Anticipate and address programming issues to support efficient programming and peer or sponsor review


• Prepare for and conduct effective internal meetings, distribute information and minutes, and track action items


• Negotiate time estimates and complete study programming activities within allotted timeframes


• Act as lead statistical programmer, direct other programming personnel and monitor deliverables


• Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs and SAS database designs


• Participate in sponsor, kickoff and bid defense meetings as the statistical programming representative


• Mentor programming personnel through training, work review, feedback and process guidance


• Transfer deliverables and perform other assigned work-related duties

Requirements

• Undergraduate degree, preferably in a scientific or statistical discipline


• In lieu of a degree, an equivalent combination of education and demonstrated programming experience


• Extensive programming experience in SAS or other required software, preferably in a clinical trial environment


• Excellent written and verbal communication skills


• Ability to read, write, speak and understand English


• Knowledge of applicable SOPs, work instructions and relevant regulatory guidelines such as ICH

Core Competencies

Demonstrates extensive programming experience in SAS, with a strong focus on developing custom code for statistical analysis in clinical trial environments. Capable of managing project timelines, ensuring quality outputs, and mentoring programming personnel while adhering to regulatory guidelines.

Highest-signal resume keywords

• SAS Programming


• Statistical Analysis Plans


• Clinical Trial Experience


• Regulatory Guidelines (ICH)


• Project Management

ATS Optimization Keywords

Hard Skills

• Custom Programming Code Development


• Validation Programming


• Data Listings Generation


• Graph Creation


• Derived Datasets Creation


• Quality Control


• Dataset Specifications Development


• Programming Specifications Review


• Statistical Programming Leadership


• Documentation Maintenance

Soft Skills

• Excellent Written Communication


• Excellent Verbal Communication


• Team Collaboration


• Mentoring


• Problem Solving

Industry Keywords

• SOPs


• Work Instructions


• Regulatory Compliance


• Clinical Trials


• Biostatistics