Senior Statistical Programmer, Clinical Pharmacology

Jobtailor; Hyderabad; On-site; INR 1,000,000 - 1,500,000; Full time

Job summary

Jobtailor in Hyderabad, India is seeking an experienced Statistical Programmer to develop SAS-based code for clinical trial outputs, including tables, listings, graphs, and derived datasets. You will ensure outputs meet quality standards and sponsor requirements.

The role emphasizes validation programming, mentoring, and collaboration with Programmers and Biostatisticians across multiple projects, with strong documentation and governance practices.

Qualifications

• Undergraduate degree in a scientific or statistical discipline or equivalent 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 statistical analysis plans, programming specifications, annotated CRFs, and SAS database design.
• Ability to perform validation programming and quality control.
• Ability to lead statistical programming activities.
• Ability to manage multiple projects, schedules, priorities, and timelines.

Responsibilities

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets
• Ensure outputs meet quality standards and project requirements
• Perform validation programming and resolve discrepancies with Programmers, Biostatisticians, and project team members
• Maintain complete, current project documentation, testing, verification, and quality-control records
• Manage scheduling and time constraints across multiple projects
• Develop dataset and output specifications according to statistical and sponsor requirements
• Anticipate and address programming issues and define variables for peer review and sponsor/requestor acceptance
• Prepare for and conduct internal meetings, distribute information and minutes, and follow action items through completion
• 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 guidance
• Transfer deliverables and perform other assigned work-related duties

Skills

SAS Programming

Statistical Analysis Plans

Validation Programming

Quality Control

Project Management

Team Collaboration

Mentoring

English Communication

Clinical Trial Experience

Education

Undergraduate degree in a scientific or statistical discipline

Tools

SAS

Job description

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


• Ensure outputs meet quality standards and project requirements


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


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


• Manage scheduling and time constraints across multiple projects


• Develop dataset and output specifications according to statistical and sponsor requirements


• Anticipate and address programming issues and define variables for peer review and sponsor/requestor acceptance


• Prepare for and conduct internal meetings, distribute information and minutes, and follow action items through completion


• 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 guidance


• Transfer deliverables and perform other assigned work-related duties

Requirements

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of 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


• Ability to develop custom programming code for clinical trial outputs


• Knowledge of statistical analysis plans, programming specifications, annotated CRFs, and SAS database design


• Ability to perform validation programming and quality control


• Ability to follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH


• Ability to lead and direct statistical programming activities


• Ability to manage multiple projects, schedules, priorities, and timelines

Core Competencies

Demonstrates extensive programming experience in SAS for clinical trial outputs, ensuring quality control and adherence to statistical analysis plans. Capable of leading statistical programming activities while managing multiple projects and timelines effectively.

Highest-signal resume keywords

• SAS Programming


• Statistical Analysis Plans


• Validation Programming


• Quality Control


• Project Management

Hard Skills

• Custom Programming Code Development


• Data Listings Generation


• Summary Tables Creation


• Graph Generation


• Dataset Specifications Development


• Statistical Database Design


• Programming Specifications Knowledge


• Annotated CRFs Understanding


• Quality Standards Compliance


• Regulatory Guidelines Knowledge

Soft Skills

• Excellent Written Communication


• Excellent Verbal Communication


• Mentoring


• Team Collaboration


• Negotiation

Industry Keywords

• Clinical Trial Environment


• SOPs


• WIs


• ICH Guidelines


• Project Documentation