Career Opportunities at IQVIA

About the job

IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we are in is cutting edge for therapies with un-met medical need.

BASIC FUNCTIONS:

Senior Clinical Data Specialist position is to ensure a quality database per industry standards and client specifications, while being a leader within the department as a subject matter expert for a system and/or process.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Clinical Data and Query Review:

• Create listings using ad hoc query tools
• Issue queries and review query responses with the highest level of quality based upon the Data Review Plan, Manual Review (Tumor Response, AE/CM compares), and Reconciliation (Laboratory, SAE, ECG, and other vendors)
• Assist other data reviews for Biostatistics, Medical Review, Client, and other ad hoc reports

Oversees System Development:

• Create or draft CRF design, edit check specification and DM listings
• Consolidate comments from internal/sponsor for discussion and approval
• Ensure all non-DM activities related to database development are completed in a timely manner

Subject matter expert for DM product or process:

• Create and Update SOPs/WP related to the product or process
• Provide training for DM and other staff members on process and/or product implementation
• Consult with DM leads or other team members on implementation and best practices
• Participate in user group meetings as the IQVIA Biotech representative

Study Management:

• May serve as Lead DM or Back-up DM lead
• Produce and Review Metric reports for internal/external project team
• Provide feedback to improve the system or reports
• Discuss roadblocks for getting processes done in a timely manner
• Review project budgets and staffing projections for data management activities
• Provide the DM lead or PM with status updates on tasks that are assigned
• Assist with the on the job training of DM staff for the study

KNOWLEDGE, SKILLS AND ABILITIES:

• Team player with ability to work well with technical and clinical team members
• Ability to collaborate with entire clinical team (CRAs, Safety, Bios, etc.)
• Excellent knowledge of clinical data concepts including knowledge of unique data collection concepts (RECIST, CDISC/CDASH, Labs, Adjudication, etc.)
• Ability to adhere to and create detailed DM study instructions and documents (CRF guidelines, Trial Design Document, edit check specifications, etc.)
• Ability to perform research for data collection and protocol specific topics
• Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)
• Organized and thorough with attention to details
• Effective Interpersonal skills and excellent communications skills, verbal, written and listening
• Ability to learn new things, teach others, and accept constructive criticism
• Effective logical thinking ability regarding Problem-solving skills
• Proficiency in computer applications (Windows, Excel, Word, Outlook etc.)
• Ability to work independently

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PURPOSE

Provide advanced technical expertise as part of a team to develop and maintain clinical systems to meet internal and external client needs. Plan and coordinate database design and development for local, regional, or transnational use. Provide leadership to the Clinical Data Programming department in the area of technical expertise.

Responsibilities

• Serve as Lead Programmer on the corporate team.
• Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
• Provide expert technical expertise in conjunction with internal and external clients.
• Program, test, and document databases in accordance with programming standards and validation procedures.
• Program database manipulation and transfer of data for internal and external clients.
• Mentor other team members and lead Programmers in training and developing technical and/or database expertise.
• Independently bring project solutions to the CDP teams and the Clinical Data Programming department.
• May assist IT in evaluating and implementing new technologies.
• May assist IT in testing and evaluating new upgrades to technologies.
• May assist in developing, revising, and maintaining core operating procedures and working instructions.
• Meet objectives as assigned, and interact with the project team to organize timelines, responsibilities and deliverables.
• Develop and maintain good communications and working relationships with teams and external clients.

Required Knowledge, Skills And Abilities

• Clinical Data Programming: Excellent knowledge of Oracle and/or SAS
• Laboratory Data Programming: Expert knowledge of VGL and/or BizTalk and/or C# and/or .NET
• Solid understanding of clinical drug development process
• Excellent organizational, communication, and technical database skills
• Ability to establish and maintain effective working relationships with co-workers, managers and clients

Minimum Required Education And Experience

• Bachelor’s degree, or educational equivalence, in computer/life science or related field with 3 years of relevant work experience; or equivalent combination of education, training and experience

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Job Profile Summary
Prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures. Interpret analyses and write statistical sections of study reports. 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.
• Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration.

Minimum Required Education And Experience

• Typically requires 2 - 3 years of prior relevant experience.
• Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
• Bachelor's Degree in Biostatistics or related field and 1 - 3 years relevant experience
• Master's Degree in Biostatistics or related field and 1 - 3 years relevant experience
• Ph.D. in Biostatistics or related field

Skills And Abilities

• 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 StatXact and R.
• Strong commitment to quality.
• Ability to effectively manage multiple tasks and projects.
• Ability to provide and accept direction of lead team members.
• 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).

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About the job

Job Overview

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: Share 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.
• Other Responsibilities: As defined on ad-hoc basis by managers. May assist with cross functional collaboration.

Qualifications, Knowledge And Skills

• 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 and R.
• 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).