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Biostatistical Programming Sr Mgr

8-10 years
Not Disclosed
10 June 19, 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 Senior Manager


Job Summary

Amgen, a leader in biotechnology and pharmaceutical innovation, is hiring a Biostatistical Programming Senior Manager for its Hyderabad, India site. This pivotal role involves leading technical teams within the Centre for Observational Research (CfOR) to manage Real-World Evidence (RWE) programming activities using large healthcare data assets such as EHR and claims databases. The ideal candidate will bring strong statistical programming expertise in SAS and SQL, leadership capability, and familiarity with RWD generation in pharmaceutical research settings.


Key Responsibilities

  • Lead and develop technical programming and process improvement initiatives.

  • Oversee statistical programming projects and ensure timely, high-quality deliverables.

  • Collaborate with epidemiologists, RWE programming leads, and global teams.

  • Ensure adherence to departmental SOPs and regulatory standards.

  • Review and approve programming plans, dataset specifications, and key documents.

  • Develop, test, and validate software programs and departmental utilities.

  • Manage outsourced programming resources and ensure output quality.

  • Participate in audits, inspections, and controlled document development.

  • Recruit, train, and manage biostatistical programming staff.

  • Contribute to scientific excellence by engaging in external professional forums.


Required Skills & Qualifications

  • Doctorate with 2+ years OR Master’s with 8–10 years OR Bachelor’s with 10–14 years OR Diploma with 14–18 years in Computer Science, Statistics, Mathematics, Life Sciences, or related field.

  • Minimum 8 years in statistical programming (preferably RWE).

  • Hands-on expertise in SAS and SQL; R and Python preferred.

  • Strong knowledge of OMOP Common Data Model and real-world data such as MarketScan, Optum, Flatiron, Medicare.

  • Experience in leadership, resource allocation, and project management.

  • Deep understanding of clinical trial data and drug development lifecycle.

  • Excellent communication, problem-solving, and teamwork skills.


Perks & Benefits

  • Competitive salary aligned with local industry standards.

  • Comprehensive Total Rewards package.

  • Opportunities for professional development and global collaboration.

  • Inclusive, supportive, and innovation-driven culture.


Company Description

Amgen is a globally recognized biotechnology pioneer dedicated to advancing healthcare through cutting-edge medicines and manufacturing excellence. With a strong focus on RWE and clinical data sciences, Amgen remains at the forefront of pharmaceutical research and development worldwide.


Work Mode

On-site (Hyderabad, India)


Salary/Compensation

Not disclosed in the job description.


Call to Action

Lead the future of Real-World Evidence and clinical programming with Amgen. Apply now for the Biostatistical Programming Senior Manager role and make a lasting impact in global healthcare data sciences.