Company Description

Avance Clinical is a globally recognized full-service Contract Research Organization (CRO) with headquarters in Australia and operations spanning New Zealand, Asia, North America, and Europe. Specializing in early phase clinical trials, the company provides biotechs with an accelerated pathway to clinical success by leveraging unique advantages like rapid ethics approval and a 43.5% R&D tax rebate. With three decades of expertise across 250+ indications and multiple therapeutic areas, Avance Clinical delivers globally accepted data recognized by leading regulators such as the FDA, EMA, and TGA. Known for their personalized service, Avance Clinical offers tailored and flexible solutions, ensuring cost-effectiveness and agility for clients worldwide.

Role Description

This is a full-time on-site 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. The role also entails providing guidance and mentorship to junior programmers.

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

· Formal training in SAS programming (desirable).

· Knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes.

· Excellent MS Word and Excel skills.

· Excellent time management and organisational skills.

· Demonstrated initiative, trust and reliability and the ability to work unsupervised.

· Excellent verbal and written communications skills.

· Willingness to work in, and be supportive of, a positive and dynamic team culture.