Principal Biostatistician at IQVIA
Durham, NC 27701
About the Job
Job Location: Home-basedJob DescriptionDevelop 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 FunctionsProduction 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.QualificationsBachelor'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 ReqTypically 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 clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide
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 $115,900.00 - $243,900.00
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.SummaryLocation: Durham, North Carolina, United States of America; Fort Worth, TX, United States of America; New York City, New York, United States of America; Seattle, WA, United States of America; Dallas, Texas, United States of AmericaType: Full time
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 FunctionsProduction 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.QualificationsBachelor'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 ReqTypically 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 clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide
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 $115,900.00 - $243,900.00
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.SummaryLocation: Durham, North Carolina, United States of America; Fort Worth, TX, United States of America; New York City, New York, United States of America; Seattle, WA, United States of America; Dallas, Texas, United States of AmericaType: Full time
