Senior /Principal Statistical Programmer

Avance Clinical Pty Ltd.; Bengaluru South; Hybrid; INR 1,800,000 - 2,400,000; Full time

Job summary

Avance Clinical in Bengaluru is seeking a Senior/Principal Statistical Programmer to develop, validate, and maintain SAS programs for clinical trial data, outputs, and documentation. You will collaborate with biostatisticians and data management teams to ensure regulatory compliance and high-quality outputs.

The role requires 8+ years in statistical programming, strong CDISC/SDTM knowledge, and experience in Oncology Therapeutics. Hybrid on-site work supported by Avance Clinical.

Qualifications

• Ordinary degree in the relevant discipline or equivalent industry experience.
• Minimum 8 years’ experience in statistical programming in pharmaceutical/health research.
• Minimum 2-3 years in Oncology Therapeutics Area Programming.
• Strong CDISC knowledge and SDTM conversion experience.
• Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards.

Responsibilities

• Preparation of listings, tables and figures for clinical study reports.
• Creation of primary and QC SAS programs for CDISC datasets and associated documentation.
• Assists with the preparation of statistical analysis plans and randomization schedules.
• Liaising with Data Management team and bioanalytical laboratories regarding data transfer.
• Management of programming tasks and deliverables to meet project timelines.
• Maintain and coordinate CDISC standards and ongoing process improvements.
• Stay current with evolution of CDISC standards and contribute to process documentation.
• Contribute to development and improvement of Avance procedures related to statistical programming.

Skills

Statistical programming

SAS programming

CDISC SDTM

Clinical trials

Education

Ordinary degree in a relevant discipline

Tools

SAS

Job description

Who are we?

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Who are we?

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Why should you join Avance Clinical?

We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

Broad Purpose

This is a full-time on-site/hybrid role for a Statistical Programmer based in Bengaluru. The Senior/Principal Statistical Programmer will be responsible for developing, validating, and maintaining statistical programming outputs including datasets, listings, tables, and graphs for clinical trials. This role involves collaborating with biostatisticians and data management teams, programming complex algorithms, writing macros, managing datasets, and ensuring compliance with regulatory requirements.

Core Responsibilities

• Preparation of listings, tables and figures for clinical study reports.
• Creation of primary and QC SAS programs for CDISC datasets and associated documentation.
• Assists with the preparation of statistical analysis plans (including preparation/review of listing, table and figure shells) and randomization schedules.
• Liaising with Data Management team and bioanalytical laboratories regarding data transfer.
• Management of project specific programming tasks and deliverables (including maintenance of planning documents and regular communication with internal stakeholders) to ensure project team will provide statistical programming deliverables according to project timelines.
• Maintain and coordinate CDISC standards, ensure maximum reuse of applied standards and involvement in ongoing process improvement initiatives
• Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation
• Contribute to the development and improvement of Avance procedures related to statistical programming.
• Other duties as directed by Line Management or delegate.

Qualifications, Skills And Experience

• Ordinary degree in the appropriate discipline or appropriate industry experience.
• Minimum 8 years’ experience in statistical programming in pharmaceutical / health research.
• Minimum 2-3 years in Oncology Therapeutics Area Programming
• Strong CDISC knowledge and SDTM conversion experience
• Experience with development, documentation, and testing of analysis data and programming code to meet regulatory and company standards