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  • Posted: Apr 1, 2021
    Deadline: Not specified
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  • IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services,...
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    Principal Statistical Programmer

    We currently require sponsor dedicated, experienced programmers to provide technical expertise to develop process methodology for the department to meet internal clients’ needs. Plan and coordinate the development of integrated programming solutions serving the full spectrum of statistical programming needs. Provide technical expertise and leadership to the department. Provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.

    Job Details:

    • Min 4+ years of CRO/Pharma Industry
    • TherapeuticAreas: Oncology // Immunology // IDV // EDCP

    Key Skills:
     

    • Must have expertise of SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
    • Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.
    • Must have excellent knowledge of CDISC standards (SDTM andADaM)
    • Thorough understanding of relational database components and theory.
    • Excellent application development skills.
    • Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis and reporting of analysis results.
    • Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
    • Minimum of 8+ years of experience in Statistical Programming in pharmaceutical or medical devices industry
    • Good verbal and written communication skills.
    • Ability to work on multiple projects, plan, organize and prioritize activities.

    Required Knowledge, Skills and Abilities:

    • Experience as technical team lead directly engaging clients and coordinating tasks within a programming team
    • In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines 
    • Knowledge of statistics, programming and/or clinical drug development process
    • Advanced knowledge of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language
    • Should have experience with SDTM Implementation andADaMimplementation according to CDISC Standards.
    • Must have expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL.
    • Good organizational, interpersonal, leadership and communication skills
    • Ability to independently manage multiple tasks and projects
    • Ability to delegate work to other members of the SP team
    • Excellent accuracy and attention to detail
    • Ability to delegate work to other members of the SP team [SPM]
    • Exhibits routine and occasionally complex problem-solving skills
    • Ability to lead teams and projects and capable of managing at a group level
    • Recognizes when negotiating skills are needed and seeks assistance.
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

    Responsibilities:
     

    • Perform, plan co-ordinate and implement the following for complex studies: (i) the programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing and (ii) the programming of analysis datasets (derived datasets) and transfer files  for internal and external clients and (iii) the programming  quality control checks for the source data and report the data issues periodically..
    • Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
    • Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
    • Fulfill project responsibilities at the level of technical team lead for single complex studies or group of studies.
    • Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
    • Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
    • Use and promote the use of established standards, SOP and best practices.
    • Provide training and mentoring to SP team members and Statistical Programming department staff.

    MINIMUM REQUIRED EDUCATION AND EXPERIENCE:

    • Bachelor's degree from reputable university preferably in science/ mathematics related fields

    At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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    Principal Biostatistician

     

    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: 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.

    Qualifications

    • 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).

    At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

    Method of Application

    Use the link(s) below to apply on company website.

     

    Note: Never pay for any training, certificate, assessment, or testing to the recruiter.

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