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Statistician, Reference Standards Evaluation

Usp
USP
5+ years
Not Disclosed
Hyderabad
10 May 12, 2026
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Location / Work Mode

  • Location: [City, State / Remote / Hybrid / Onsite]

  • Work Schedule: [Shift / Mon–Fri / Nights if applicable]

Company Overview

[2–4 lines about company, its mission, and domain]

Job Summary

Brief 4–6 line summary describing:

  • Purpose of the role

  • Domain (Clinical Research / Pharma / R&D / Regulatory etc.)

  • Key responsibility area (operations, research, data, compliance, etc.)

Key Responsibilities

  • List major responsibilities in action-oriented bullets

  • Start each bullet with a verb (e.g., Perform, Manage, Support, Lead, Review)

Example structure:

  • Perform end-to-end [process/activity] as per SOPs and regulatory guidelines

  • Support cross-functional teams in execution of [study/process/project]

  • Review and ensure accuracy of [data/documents/outputs]

  • Maintain compliance with GCP / GLP / GMP / ICH / FDA / EMA guidelines

  • Prepare reports, dashboards, or technical documentation

  • Identify risks, deviations, and support CAPA implementation

Required Qualifications

  • Education: [BSc/MSc/PhD/MBBS/Engineering/Pharmacy etc.]

  • Experience: [X–Y years in relevant domain]

  • Domain exposure: [Clinical Research / Pharma Manufacturing / R&D / PV / Data Mgmt etc.]

Required Skills

  • Strong understanding of [domain-specific systems/processes]

  • Regulatory knowledge (GCP / GMP / GLP / ICH / FDA / EMA as applicable)

  • Strong analytical and problem-solving skills

  • Good communication and stakeholder management

  • Proficiency in tools (Excel / SAS / R / EDC systems / Veeva / SQL etc.)

Preferred Skills (Optional)

  • Global study exposure / CRO experience

  • Advanced tools or platform experience

  • Audit / inspection readiness exposure

  • Leadership or mentoring experience

Work Environment

  • Office-based / Remote / Hybrid

  • May include shift work or global collaboration

  • Exposure to regulated environment (if applicable)

Why Join Us

  • Career growth opportunities

  • Global exposure

  • Learning & development

  • Contribution to healthcare / science / patient safety


Example (Clean JD Style – Clinical Data Associate II)

Job Title

Clinical Data Associate II

Location / Work Mode

Remote / Onsite (as applicable)
Standard working hours (Mon–Fri)

Job Summary

The Clinical Data Associate II is responsible for ensuring high-quality clinical trial data management across assigned studies. The role focuses on data review, query management, reconciliation activities, and supporting inspection readiness in compliance with GCP and internal SOPs.

Key Responsibilities

  • Perform clinical data review and identify discrepancies across study datasets

  • Generate, track, and resolve data queries within EDC systems

  • Conduct SAE and third-party vendor data reconciliations

  • Review data listings and validation outputs for accuracy and completeness

  • Support CRF design updates and database maintenance activities

  • Prepare project status reports and communicate findings to stakeholders

  • Ensure compliance with GCP, SOPs, and regulatory requirements

  • Support audit readiness and inspection preparation activities

Qualifications

  • Bachelor’s degree in Life Sciences / Pharmacy / related field

  • 4+ years of clinical data management experience

  • Hands-on experience in RAVE / Veeva EDC preferred

Skills

  • Strong analytical and attention-to-detail skills

  • Good knowledge of clinical trial processes and terminology

  • Proficiency in MS Office and clinical databases

  • Strong communication and documentation skills

Work Environment

Office-based or remote collaboration with global clinical teams