Principal Statistical Programmer

4+ years

Not Disclosed

Bangalore Mumbai Pune

10 Jan. 28, 2025

Job Description

Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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

Job Title: Principal Statistical Programmer

Available Locations: 3 (specific locations not mentioned)
Category: Clinical
Job ID: 2444693

About Fortrea

Fortrea is a global contract research organization (CRO) that combines decades of clinical development experience with scientific expertise. Serving pharmaceutical, biotechnology, and medical device clients, Fortrea operates in over 100 countries and offers services across 20+ therapeutic areas. The organization is committed to transforming drug and device development to deliver life-changing therapies to patients worldwide.

Key Responsibilities

Lead Statistical Programming Activities

Serve as the Lead Statistical Programmer, overseeing all programming tasks on a study.
Plan and manage programming activities, including resource estimation, budget adherence, and timeline management.
Collaborate with other departments and clients to ensure high-quality deliverables.

SAS Programming and Dataset Development

Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs (Tables, Listings, and Figures).
Perform quality control (QC) of SDTM datasets, ADaMs, and TFLs.
Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs (aCRFs), and Reviewers’ Guides to support SDTMs and ADaMs.

Specifications Development and Review

Develop and/or lead the creation of complex specifications for SDTM and ADaM datasets.
Contribute to the development of Fortrea and client-specific standards.
Review statistical analysis plans (SAPs) and TFL shells for programming feasibility and provide input on complex TFL shells.

Mentorship and Knowledge Sharing

Mentor junior programmers on SDTM, ADaM, and TFL development processes, ensuring adherence to departmental practices and standards.
Present and share expertise at departmental meetings.

Audit Support and Client Interaction

Respond to quality assurance (QA) and client audits.
Support qualification audits as needed.
Contribute to proposal activities and participate in bid defense meetings to secure new business opportunities.

Continuous Improvement

Identify and propose enhancements to improve efficiency, quality, and productivity in statistical programming processes.
Execute all other duties as assigned or required.

Qualifications

Education and Experience

Expertise in SAS programming and statistical data management.
Proven ability to lead and manage statistical programming tasks on clinical studies.
Experience with SDTM and ADaM dataset creation and QC processes.

Skills and Competencies

Strong understanding of clinical trial processes, statistical analysis, and regulatory requirements.
Excellent problem-solving, communication, and mentoring skills.
Ability to work effectively in a collaborative, cross-functional team environment.

Why Join Fortrea?

At Fortrea, we aim to break barriers in clinical trials and accelerate the development of life-changing therapies. Join our collaborative team, where innovation and personal growth are prioritized, and make a global impact in healthcare.

Equal Opportunity Employer

Fortrea promotes diversity, equity, and inclusion, ensuring a harassment-free and discrimination-free work environment. Employment decisions are based solely on business needs and qualifications.

For reasonable accommodation requests, please contact taaccommodationsrequest@fortrea.com.

Visit www.fortrea.com for more information.

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