Principal Statistical Programmer

3+ years

Not Disclosed

Mumbai

10 April 18, 2025

Job Description

Job Type: Full Time Education: BA/BS/MS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Principal Statistical Programmer
Job ID: REQ-10031239
Date: Apr 01, 2025
Location: India

Summary:
The Principal Statistical Programmer is responsible for all statistical programming aspects of a large/pivotal study, several studies, or project-level activities (including submission activities). This position is a key collaborator with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high-quality deliverables in Novartis Global Drug Development.

About the Role:
Major Accountabilities:

Lead statistical programming activities as Trial Programmer for either a large/pivotal study or several studies, or act as a Lead/Program Programmer for a small to medium-sized project in phase I to IV clinical studies in Novartis Global Drug Development.
Coordinate activities of all programmers either internally or externally assigned to the study/project work, mentor other programmers in functional expertise and processes. Make statistical programming decisions/recommendations at study or project level.
Build and maintain effective working relationships with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g., as a member of the extended Clinical Trial Team (CTT).
Review eCRF, discuss data structures, and participate in data review activities as a member of the extended CTT.
Comply with company, department, and industry standards (e.g., CDISC) and processes, assess and clarify additional programming requirements at project level, review and develop programming specifications as part of the analysis plans.
Provide and implement statistical programming solutions; ensure knowledge sharing.
In consultation with the Statistician, responsible for the development of programming specifications of analysis datasets and pooled datasets.
Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications, or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.
Maintain up-to-date advanced knowledge of programming software (e.g., SAS) as well as industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
Establish successful working relationships on individual studies with external associates according to agreed contract and internal business guidance.
As assigned, act as subject matter expert (SME) or contribute to process improvement/nonclinical project initiatives with a focus on programming and analysis reporting procedures.

Key Performance Indicators:

Quality and timeliness of statistical programming deliverables and contributions as assessed by internal and external customers, including the Clinical Trial Team, Lead/Program Statistician, and the functional/operational manager.
Adequate representation of the Statistical Programming function as Trial/Lead/Program Programmer in the Clinical Trial Team(s). Effectiveness of communication and team behaviors as assessed by the team members.
Ability and effectiveness in training, mentoring, and coordinating internal and external programmers assigned to the same study/project as assessed by the functional/operational manager.

Job Dimensions:

Number of associates: No direct reports. Coordination of 5+ internal and external programmers.
Financial responsibility: None
Impact on the organization:
- Timely, high-quality, and efficiently produced statistical programming deliverables included in study and project-level documents (including submissions).
- Reliable and compliant statistical analysis results presented externally (including submissions).
- Innovative technical solutions to support timely and efficient drug development deliverables.

Ideal Background:
Education (minimum/desirable): BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences, or related field.
Languages: Fluent English (oral and written).

Experience/Professional Requirements:

Advanced SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables.
Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications.
Good knowledge of industry standards, including CDISC data structures, as well as a solid understanding of the development and use of standard programs.
Good understanding of regulatory requirements relevant to Statistical Programming (e.g., GCP, study procedures).
Good communications and negotiation skills, ability to work well with others globally.
Experience as Trial Programmer, including coordination of internal or external programmers on a given study/project.
Ideally 5+ years of work experience in a programming role, preferably supporting clinical trials or in the pharmaceutical industry.

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Principal Statistical Programmer

Job Description

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