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Biostatistical Programming Mgr

6-8 years
Not Disclosed
10 May 1, 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

 

Job Title: Biostatistical Programming Manager

Location: India – Hyderabad (On Site)
Job ID: R-209284
Date Posted: March 4, 2025
Category: Clinical
Company: Amgen


Job Summary

Amgen is seeking a Biostatistical Programming Manager to lead programming activities within the Centre for Observational Research (CfOR), focused on real-world evidence (RWE) generation from real-world data (RWD). This leadership role includes managing team performance, overseeing global collaborations, and contributing to technical and strategic initiatives in clinical research.


Key Responsibilities

  • Provide technical solutions and lead programming/process improvement initiatives.

  • Manage programming projects, timelines, and resource allocations.

  • Develop and approve programming plans and dataset specifications.

  • Write and validate Unix-based software programs for datasets, tables, and figures.

  • Ensure compliance with SOPs and departmental standards.

  • Oversee external/outsourced programming resources.

  • Lead or contribute to internal policy, SOP, and document development.

  • Participate in audits, recruitment, and professional conferences.

  • Guide team performance and contribute to strategic growth within CfOR and R&D.


Basic Qualifications

  • Doctorate degree OR

  • Master’s degree + 4–6 years of experience OR

  • Bachelor’s degree + 6–8 years of experience OR

  • Diploma + 10–12 years of experience
    Fields: Computer Science, Statistics, Mathematics, Life Sciences, Economics, or related disciplines


Preferred Qualifications

  • Proven managerial or leadership experience in biostatistical programming

  • Experience with OMOP common data model

  • Programming expertise: SQL and SAS or R (required), Python (preferred)

  • RWE experience in pharmaceutical or clinical research

  • Familiarity with claims and EHR datasets (e.g., MarketScan, Optum, Flatiron)

  • Knowledge of CDISC standards (SDTM, ADaM) for regulatory roles


Key Competencies

  • Advanced hands-on programming and leadership

  • Strong communication and collaboration skills

  • Agile project management and global teamwork

  • Expertise in real-world data and drug development processes

  • Scientific excellence, attention to detail, and innovation mindset


Why Join Amgen

  • Work on global, data-driven healthcare solutions

  • Strong focus on leadership development, innovation, and collaboration

  • Comprehensive total rewards and growth opportunities


How to Apply

Visit: careers.amgen.com