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Senior Statistical Programmer Specialist

5-6 years
Not Disclosed
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: Senior Statistical Programmer Specialist

Location: Bangalore
Category: Clinical
Job ID: 2444697


About Fortrea

Fortrea is a global Contract Research Organization (CRO) dedicated to advancing drug and device development. With decades of clinical development expertise and operations in over 100 countries, Fortrea supports pharmaceutical, biotechnology, and medical device organizations across more than 20 therapeutic areas. By blending innovation and scientific rigor, we are revolutionizing clinical research to deliver life-changing therapies to patients worldwide.


Key Responsibilities

Statistical Programming and Lead Support

  1. Act as a Lead Statistical Programmer for CP (clinical pharmacology) studies, with guidance from senior programming staff.
  2. Plan, execute, and oversee all programming activities for assigned studies, including resource estimation, timeline adherence, and budget management.
  3. Collaborate with cross-functional teams and clients to ensure high-quality deliverables.

SAS Programming and Dataset Development

  1. Develop and maintain SAS programs to create SDTM and ADaM datasets, as well as Tables, Listings, and Figures (TFLs).
  2. Perform quality control (QC) of SDTM datasets, ADaMs, and TFLs to ensure accuracy and compliance.
  3. Generate Define XML/PDFs, Analysis Results Metadata (ARM), annotated eCRFs, and Reviewers' Guides to support SDTM and ADaM datasets.

Specifications Development and Review

  1. With support from senior programming staff, contribute to the development of specifications for SDTM and ADaM datasets.
  2. Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective, with guidance from senior staff.

Audit Support and Compliance

  1. Assist in responding to Quality Assurance (QA) and client audits with the support of senior programming staff.

Other Duties

  1. Participate in any additional responsibilities or tasks assigned by the organization to support programming operations.

Qualifications

Education and Experience

  • Proficiency in SAS programming and statistical data management for clinical studies.
  • Hands-on experience with SDTM, ADaM datasets, and TFL creation.
  • Familiarity with clinical pharmacology studies and related data requirements.

Skills and Competencies

  • Strong analytical and problem-solving skills.
  • Ability to work collaboratively in a team environment with guidance from senior staff.
  • Excellent organizational and communication skills.

Why Join Fortrea?

Fortrea offers a dynamic work environment focused on innovation, collaboration, and personal growth. As a Senior Statistical Programmer Specialist, you will play a vital role in advancing clinical research and transforming ideas into impactful therapies for patients worldwide.


Equal Opportunity Employer

Fortrea is committed to fostering a diverse and inclusive workforce. Employment decisions are based on business needs and individual qualifications, free from discrimination or harassment of any kind.

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

Visit www.fortrea.com for more information.