Job Title:
FSP Principal Biostatistician – Early Phase Clinical Development (PK)
📍 Durham, North Carolina (Home-based in the U.S. or Canada)
🕒 Full-Time
📄 Job ID: R1478711
🌍 Available in additional locations
Company Overview
IQVIA’s Data Sciences Staffing Solutions (DS3) delivers fully embedded resources via Functional Service Provider (FSP) partnerships. Working directly within sponsor teams and systems, DS3 supports world-class pharmaceutical and biotech clients to accelerate drug development and bring new therapies to market.
🌐 Learn more: https://jobs.iqvia.com
Why Work with DSSS?
Remote, home-based work opportunities
Work/life balance with flexible schedules
Collaboration with motivated, high-performance statistical and research teams
Technical training and tailored development curriculum
Research projects aligned with your skillset
Promising career growth and trajectory
Long-term job stability and re-deployment opportunities
Focus on advancing new therapies rather than project budgets
Engaging, fast-paced work environment
Job Summary
Provide statistical support for early phase drug development programs, primarily focusing on healthy volunteer studies with pharmacokinetic (PK) and pharmacodynamic (PD) endpoints.
Key Responsibilities
Collaborate with multidisciplinary project teams to establish timelines
Provide statistical input for study synopses and protocols
Write statistical sections of clinical trial protocols, including sample size calculations
Review eCRF and other data management documents
Create or review randomization schemes and related specifications
Write or review statistical analysis plans (SAP), dataset, and tables/listings/figures (TLF) specifications
Guide and supervise programmers in dataset authoring and programming of TLFs
Perform statistical review and validation of datasets and outputs
Use SAS and/or R to perform inferential analyses and validate key data derivations
Interpret study results and review accuracy of study reports
Monitor internal and CRO project activities including timelines and deliverables
Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK teams
Contribute to clinical study reports and other regulatory documents (e.g., DSURs, Investigator Brochures)
Support exploratory analyses and may assist in IND-related activities
Minimum Qualifications
PhD in Statistics, Biostatistics, or related field with 3+ years industry experience
OR MS in Statistics, Biostatistics, or related field with 5+ years industry experience
Minimum 2 years experience analyzing non-compartmental PK endpoints in the pharmaceutical industry
Understanding of ICH GCP, clinical pharmacology regulatory guidance, and industry standards
Experience with CDISC standards including SDTM, ADaM, CDASH
Ability to work independently with strong project management and decision-making skills
Effective communication skills and ability to manage programmers constructively
Proficiency in SAS for performing analyses and data validation
Desired Experience
Knowledge of basic statistical modeling, simulations, and PD/biomarker analyses
Compensation & Benefits
💰 Annual Salary Range:
$115,900 – $243,900 (varies by qualifications, experience, location, schedule)
Additional benefits may include incentive plans, bonuses, health and welfare programs.
Work Environment
🏠 Home-based (Remote work) in the U.S. or Canada
Equal Employment Opportunity
IQVIA is an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected status.
How to Apply
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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Bangor | Brewer |Maryland :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Berlin |Germany :
Germany | GErmany |Hesse :
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Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Richmond Hill | Uxbridge | Australia | North York | Renfrew | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Tel Aviv | Kfar Saba | Be'Er Sheva | Netanya | Yavne |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |New Zealand :
New Zealand |North Island :
Auckland |Lima Region :
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Manila |Mazovia :
Warsaw |Remote :
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Brazil | Sao paulo |South America :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Kyiv |Dubai :
Dubai |Hà Nội :
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