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Fsp Principal Biostatistician- Early Phase Clinical Development(Pk)

3-5 years
$115,900 – $243,900 annually
10 July 18, 2025
Job Description
Job Type: Full Time Education: Master’s degree /PhD 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

 

Principal Biostatistician – Early Phase Clinical Development (PK)

Location: Remote (U.S. or Canada)
Company: IQVIA – Data Sciences Staffing Solutions (DSSS)
Job Type: Full-Time

Job Summary:

IQVIA’s DSSS unit is seeking a Principal Biostatistician to support early phase drug development studies, especially pharmacokinetics (PK) and pharmacodynamics (PD) trials in healthy populations. This home-based opportunity is ideal for experienced clinical statisticians with strong SAS programming, CDISC familiarity, and a background in early-phase clinical development. Join a global CRO delivering impactful data solutions across world-class pharmaceutical and biotech sponsors.


Key Responsibilities:

  • Provide statistical guidance on protocols and study designs with a PK/PD focus

  • Contribute to sample size calculations and randomization plans

  • Write and review Statistical Analysis Plans (SAPs), TLF specs, and analysis datasets

  • Collaborate with cross-functional teams including Data Management and Clinical Pharmacology

  • Perform and validate inferential analyses using SAS or R

  • Interpret and summarize study results in clinical reports and regulatory documents

  • Guide and review statistical programming deliverables

  • Support exploratory analyses and contribute to IND documentation

  • Maintain timelines and deliverables across internal and CRO stakeholders


Required Skills & Qualifications:

  • PhD in Statistics/Biostatistics with 3+ years industry experience OR
    MS with 5+ years industry experience

  • 2+ years analyzing non-compartmental PK endpoints

  • Proficiency in SAS (and/or R) for data derivation and validation

  • Experience with CDISC standards (SDTM, ADaM, CDASH)

  • Knowledge of ICH GCP and clinical pharmacology regulatory guidance

  • Ability to lead projects independently and manage programming teams

  • Strong communication and decision-making skills


Desired Experience:

  • Familiarity with statistical modeling, PD/biomarker analysis, simulations

  • Experience in early phase, healthy volunteer trials


Perks & Benefits:

  • Salary Range: $115,900 – $243,900 annually (depending on experience and location)

  • 100% Remote work across U.S. or Canada

  • Flexible scheduling and strong work-life balance

  • Long-term FSP assignments with re-deployment opportunities

  • Exposure to novel study designs and breakthrough therapies

  • Technical training and custom career development support

  • Collaborative, global team culture in a fast-paced setting


About IQVIA:

IQVIA is a global leader in clinical research, healthcare data analytics, and real-world evidence solutions. Through DSSS (Data Sciences Staffing Solutions), IQVIA offers embedded opportunities with top-tier pharmaceutical clients, helping to shape the future of medicine.


Work Mode: Remote (Home-based in U.S. or Canada)


Apply Now

Ready to lead early phase clinical research with one of the world’s top CROs? Apply now and become a key contributor to innovative drug development at IQVIA.