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Principal Biostatistician

Durham, North Carolina Full time R1402214

Durham, North Carolina| Dallas, Texas| Texas| New York| Washington| North Carolina| Remote

  • Full Time
  • Level: Entry-level, Mid-level, Senior-level

Build a rewarding career in life sciences consulting and forge your own path. Partner with collaborative teams and leaders across unique projects and geographies, delivering innovative solutions to the most complex healthcare problems along the way. Working at IQVIA means changing outcomes for patients one data set, product offering and innovative solution at a time.

As a Consultant at IQVIA, you'll have the opportunity to grow your career and explore opportunities in brand and integrated research solutions, go-to-market strategy, commercial excellence, real world data, financial investor consulting and more.

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Success profile

What makes a Consultant at IQVIA successful? Check out the top traits we’re looking for and see if you have the right mix.


What you can expect

Professional Development

Environments that advance your skillset

Highly Specialized

Work in distinctive areas of expertise

Growth Potential

Clear pathways to success


Teams that work together to achieve common goals

Innovative Projects

Projects that solve complex problems in new ways

Best-in-Class Training

Programs to help you build knowledge and gain skills

I joined IQVIA after graduating from university and am grateful for the fantastic opportunities I’ve been able to pursue over the years. I’ve had the chance to work with inspiring managers who have supported me with professional and personal development.


Consultant, Financial Institutions

I simultaneously work on a number of customer-commissioned projects in multiple therapeutic areas using various primary research methodologies. This variety is what makes my role so interesting. It allows me to learn from my colleagues and customers alike and helps me to understand how the work we do supports the improvement of patient care.


Senior Consultant, Brand and Integrated Research Solutions

IQVIA has given me the opportunity to gain a broad range of skills and experience across multiple disease areas and at different stages of the product lifecycle. This has supported my career development and accelerated my growth. If you enjoy learning new things and working on global projects, you will definitely enjoy working at IQVIA.


Consultant, Brand and Integrated Research Solutions​

One of the things I like most about working at IQVIA is the supportive environment that helps you achieve your full potential.


Consultant, Financial Institutions

Working in healthcare consulting is inspiring! I am glad to be part of a close community that brings together diverse experiences and critical thinkers to help our customers move treatments forward that can change patients’ lives.


Principal, Consulting Services

Principal Biostatistician

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Durham, North Carolina, United States| Dallas, Texas, United States| Texas, United States| New York, United States| Washington, United States| North Carolina, United States| Remote Full time R1402214

Job description

Job Location: Home-based

Job Description
Develop statistical methods sections of protocols and review case report forms (CRFs).  Prepare analysis plans and write specifications for analysis files, tables, and figures.  Communicate with clients regarding study protocol or statistical analysis issues as they arise.  Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.  Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition.  Provide training, guidance and mentorship to lower level and new staff.

Essential Functions

  • Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution.

  • Leadership: Perform statistical team lead role on single studies. Through this, works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget. Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities. Demonstrates and promotes efficient communication.  If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting.

  • Data Management: Assist in reviewing or advising data management staff on database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision.

  • Statistical Analysis Plan (SAP) and Shells:  Authors or performs quality control review (QC) of SAPs and shells. Make best use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods). May author or QC complex SAPs, under supervision if needed.

  • Datasets:  Writes and maintains programming specifications. Programs assigned datasets to industry standards. Handles dataset derivations and assignment.

  • Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Programs TLFs, maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced.

  • Timelines:  Plans and documents timelines, forecasts resource needs, suggests work may be out of scope.

  • Financials:  Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Responsible for sharing budget expectations with the team. Raises concerns to manager if new work or rework appears to be out of scope. Understands 'scope of work' and has an awareness of contract and budget assumptions.

  • Knowledge Sharing:  Helps train staff regarding operational items. Mentors junior staff. Supports colleagues and provides motivation as needed.

  • Risk Management:  Identifies risks to project delivery and/or quality and spends time to proactively avoid as well as proposes solutions to mitigate risks. Where possible, anticipate risks to minimize need for study level escalations.

  • Other  Clinical Data Interchange Standards Consortium (CDISC) requirements:  Leadership:  Under supervision within Compound. May perform statistical team lead role on studies within a compound. In addition to the leadership responsibilities above, also prioritizes and takes proactive approach to gain efficiencies in work across protocols.

  • Study Start up:  Assist with protocol development, sample size calculation, protocol and case report form (CRF) review.

  • Protocol:  Authors or performs quality control (QC) review of the statistical section of a protocol (making best possible use of resources and expertise within the organization (e.g. Libraries, templates and consultants for complex statistical methods).

  • Proposals:  May be able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP). May be expected to present at bid defenses.

  • Clinical Study Report (CSR):  Reviews or drafts CSR or statistical report.

  • Customer:  On occasion, may serve as primary point of contact for customer. May also consult on operational topics with clients.

  • Lock and Unblinding Process:  Handles the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or reduce or perform quality control (QC) review of randomization schedules). May serve as unblinded lead statistician.


  • Bachelor's Degree Biostatistics or related field and 3 - 5 years relevant experience Req Or Master's Degree Biostatistics or related field and 3-5 years relevant experience Req Or Ph.D. Biostatistics or related field and 1 year relevant experience Req

  • Typically requires 3-5 years of prior relevant experience, or equivalent combination of education, training and experience.

  • Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.

  • Excellent written and oral communication skills including grammatical/technical writing skills.

  • Excellent attention and accuracy with details.

  • In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

  • Familiarity with moderately complex statistical methods that apply to applicable clinical trials.

  • Strong individual initiative.

  • Strong organizing skills.

  • Strong working knowledge of SAS computing package.

  • Familiarity with other relevant statistical computing packages such as nQuery.

  • Strong commitment to quality.

  • Ability to effectively manage multiple tasks and projects.

  • Ability to lead and co-ordinate small teams.

  • Ability to solve moderately complex problems.

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

  • Working knowledge of relevant Data Standards (such as Clinical Data Interchange Standards Consortium CDISC/ADaM).

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $122,800.00 - $233,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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