Principal Statistical Programmer

VAICS Consulting; Chennai District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

VAICS Consulting is seeking a Principal Statistical Programmer to lead development and maintenance of statistical programming capabilities for regulatory submissions. You will work with directors and statistics programmers to review CRO deliverables and ensure CDISC-aligned datasets and submission packages meet standards.

The role involves guiding junior team members, ensuring quality and on-time delivery, and collaborating with study teams to implement standard data practices and tools across

Qualifications

• Bachelor or Master in Statistics, Biological Sciences, IT, or related field.
• At least 7 years relevant experience in pharmaceutical, biotech, CRO, or Regulatory Agency.
• Statistical Programming and SAS hand‑on experience.
• Clinical trials expertise with an understanding of data operations for reporting.
• Good understanding of ICH and regulatory guidelines.
• Working knowledge of clinical data and relevant data standards.
• CDISC and submission experience desirable.

Responsibilities

• Hands on programming role, delivering medium/high complexity statistical programming outputs.
• Mentored/guided by Statistical Programming Leads within Standards/Study/Project.
• Guide and monitor programmers on timelines, resources, and deliverables with quality.
• Ensure adherence to programming standards and timely, compliant delivery.
• Collaborate with study teams and stakeholders on milestones and deliverables.
• Active self-learning and delivering solutions in statistical programming and data standards.
• Accountable for multiple projects within a Work Team.

Skills

Communication skills

Project management

Problem solving

Education

Bachelor/Master in Statistics or related field

Tools

SAS

CDISC

Clinical data standards

Job description

Principal Statistical Programmer is responsible for providing leadership and hands‑on support in the development and maintenance of the clients statistical programming capabilities which is required to meet regulatory obligations.

Principal Statistical Programmer will work closely with the Associate Director, Director, and Statistical Programmers to build internal programming tools. This individual, working closely with the study team will be responsible for review and acceptance of contract research organization (CRO) deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. Principal Statistical Programmer will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses

Essential Duties and Responsibilities

• Hands on programming role, supporting deliverables in the study/project/portfolio/standards team, of medium or high complex statistical programming deliverables.
• Mentored/Guided by Statistical Programming Leads within Standards/Study /Project / Portfolio /TA’s.
• Guide, mentor, monitor programmers within the team and collaborate with SPLs on timelines, resource management and deliverables with quality.
• Ensure adherence to programming standards in their daily work.
• Ensure the tasks are completed on time with quality and are compliant to the process at VAICS Consulting with needed guidance.
• Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.
• Active self-learning and delivering on solutions in the space of statistical programming and data standards.
• Accountable for multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity within a Work Team.
• Accountable for their assigned work supporting the standards/study deliverables and also assisting SPLs with the team assignments.
• Develop/Validate/Review datasets, TFL as per CDISC aligned Standards or Data Standards for Study/Project/Portfolio. (Portfolio).
• Explore the existing code base and execute/perform runs as required, also develop/modify/review as per the needs and specifications suggested to the standards team as appropriate – (Standards).
• Understand/Implement standard/study/project/portfolio requirements and specification and work with global stakeholders in ensuring completion of project/study/deliverable goals and milestones.
• Ensures appropriate documentation are completed for their deliverables and the deliverables within the team.
• Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planning.
• Advance job knowledge to next level by participating/contributing in/to opportunities both globally and locally.
• Acts as mentor to junior team members.

Job Qualification

• Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.
• At least 7 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.
• Statistical Programming and SAS hand‑on experience.
• Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.
• Good understanding of ICH and regulatory guidelines.
• Working knowledge of clinical data and relevant data standards.
• Ability to Identify and solve complex problems.
• Exposure working across boundaries, with various stake holders.
• Strong written and oral communication skills, and project management skills.
• Proven ability to operate with limited oversight
• Knowledge of at least 3 Therapeutic Area (including oncology)
• Proven ability to manage delivery under tight timelines.
• CDISC and submission experience desirable.