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Senior Statistical Programmer Specialist

3+ years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Senior Statistical Programmer Specialist
Location: Bangalore
Category: Clinical
Job ID: 2444697


Job Overview

As a Senior Statistical Programmer Specialist at Fortrea, you will take a leadership role in statistical programming for clinical trials, focusing primarily on Clinical Pharmacology (CP) studies. You will work with a dedicated team to ensure the efficient development of clinical datasets and analysis outputs. You will also manage the planning, execution, and oversight of all programming activities for assigned studies, ensuring quality and timely deliverables.

Key Responsibilities

  • Lead Programming Activities: Oversee programming activities for CP studies, including resource estimation, budgeting, timeline management, and client interaction.
  • SAS Programming: Develop and maintain SAS programs to create SDTM and ADaM datasets, TFLs, and perform QC of SDTM, ADaMs, and TFLs.
  • Documentation and Metadata: Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs, and Reviewers Guides to support SDTMs and ADaMs.
  • Collaboration with Senior Staff: Collaborate with senior programming staff to develop specifications for SDTM and ADaM datasets and review study protocols (SAPs) and TFL shells.
  • QA & Audits: Respond to QA and client audits with support from senior programming staff.
  • General Duties: Perform all other duties as required and assigned to meet the needs of the organization.

Required Qualifications

  • Experience: Sufficient experience to assume a lead role in statistical programming for CP studies.
  • Technical Skills: Expertise in SAS programming for SDTM and ADaM dataset creation, TFL generation, and quality control.
  • Collaborative Skills: Ability to interact effectively with senior programming staff, clients, and other departments.
  • Problem-Solving Skills: Strong analytical and problem-solving skills for navigating complex clinical trials.

Company Overview

Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and technology solutions in over 20 therapeutic areas. With operations in around 100 countries, Fortrea is dedicated to transforming drug and device development, speeding up the delivery of life-saving therapies to patients.

Equal Opportunity Employer Statement

Fortrea is an Equal Opportunity Employer that fosters diversity and inclusion. We are committed to providing a harassment-free and discrimination-free environment for all employees. Employment decisions are based on business needs and individual qualifications. All qualified applicants are encouraged to apply.

Accommodation

Fortrea provides reasonable accommodations for individuals who need assistance in the hiring process. Please reach out to taaccommodationsrequest@fortrea.com if you require accommodation during the application or interview process.