Statistical Programmer

Avance Clinical Pty Ltd.; Bengaluru South; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Avance Clinical is seeking a Senior Statistical Programmer to translate protocols and SAPs into robust programming specifications. You will create and validate SDTM/ADaM outputs, maintain study datasets, and ensure alignment with CSF and sponsor requirements.

You will review CRFs, manage project tasks, provide time estimates, and collaborate with Clinical Operations, Project Management, and Data Management to ensure timely, high-quality deliverables.

Qualifications

• Translate study protocol and SAP into algorithms and specifications.
• Create and/or validate study output requirements (SDTM, ADaM, TLFs).
• Manage and maintain programming specifications for SDTM, ADaM, dataset and outputs.
• Communicate statistical programming concepts and clinical principles.

Responsibilities

• Review CRFs and External Data Review Transfer Agreements.
• Lead project-specific programming tasks and deliverables with stakeholders.
• Provide accurate programming time estimates and risk plans to management.
• Identify study priorities and communicate with project teams.
• Review study documentation such as SAP and CRFs.
• Develop specifications for complex data outputs as required.

Skills

Statistical programming

SAS

CDISC standards

SDTM

ADaM

Project management

Communication skills

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.

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.

Role Description

• Translate study protocol and Statistical Analysis Plan into algorithms and specifications to achieve analysis and CDISC standards.
• Create and/or validate all safety and efficacy study output requirements (e.g. SDTM, ADaM, TLFs) consistent with data definitions and specifications and relevant study documentation (e.g. protocol, SAP, aCRF)
• Manage and maintain programming specifications for SDTM, ADaM, analysis dataset, analysis outputs, and integration of data in support of ISS/ISE.
• Communicate an understanding of statistical programming concepts, basic clinical principles and act in accordance with those principles.
• Review and provide input to Case Report Forms (CRFs) and External Data Review Transfer Agreements.
• 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.
• Provide accurate programming time estimates and risk mitigation plans to Management or Project Team.
• Identify study priorities and communicate effectively with project team and management.
• Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design.
• Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient.
• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects.
• Provide accurate and timely responses to routine requests from clients and with limited supervision responses to non-routine requests from clients.
• Responsible for identifying opportunities for productivity improvements and formulating proposal for new SAS utilities/macros and their implementation.