Jobs at IQVIA

About the job

• Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Build awareness of features and opportunities of study to site.
• Collaborate and liaise with study team members for project execution support as appropriate.

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As a Senior Statistical Programmer, you will provide experienced technical expertise to develop process methodology for the department to meet internal and external clients’ needs.
Plan and coordinate the development of integrated programming solutions, serving the full spectrum of statistical programming needs.
You will also provide technical expertise and leadership to the department and provide internal consulting services, including specifications and user needs analysis for complex project or client requirements.
Key Responsibilities:

• Perform, plan co-ordinate and implement the following for complex studies:
• The programming, testing, and documentation of statistical programs for use in creating statistical tables, figures, and listing
• The programming of analysis datasets (derived datasets) and transfer files for internal and external clients
• The programming quality control checks for the source data and report the data issues periodically
• 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.
• Fulfil 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.
• Provide training and mentoring to SP team members

Requirements:

• 5+ years Statistical Programming experience within the Life Science industry
• BSc or MSc degree in Biostatistics or related field
• Experience in SAS® Base, and good knowledge of SAS® graph and SAS® Macros
• Ability to implement more advanced statistical procedures as per specifications provided by Biostatistician.
• Excellent knowledge of CDISC standards (SDTM and ADaM)
• 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.
• Ability to work on multiple projects, plan, organize and prioritize activities
• 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

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Responsibilities:

• Import data from various sources
• Program quality control checks for source data and reporting data issues
• Interpret project level requirements and develop programming specifications
• Write programming code following established Good Programming Practices
• Program SDTM and ADaM datasets
• Program to create statistical analysis tables, listing and figures
• Validate datasets and all statistical outputs per prescribed gate checks
• Communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and timelines
• Use and promote the use of established standards, SOPs, and standard methodologies
• Export data and clinical study report materials
• Provide training and mentoring to team members and department staff
• You can help us bring clinical trial statistical analysis into the next generation. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects across therapeutic areas. Be challenged in a fast-paced team environment that is collaborative in performing biostatistical analyses and advanced statistical programming. Development opportunities and mentoring at all levels enable you to progress your long-term career in the direction you choose.

THE PERSON
We know that meaningful results require not only the right approach, but also the right people. Candidates should possess a Master’s or Bachelor’s degree in Biostatistics, Statistics, Mathematics, or Computer Science, and have a strong educational or practical evidence in programming.
Key required skills include:

• Home Based/Remote
• 5+ experience in Statistical Programmer role from CRO/Pharma with ADaM/SDTM/ TLFs
• Excellent accuracy, attention to detail, problem solving, organizational as well as interpersonal communication.
• In light of the above, candidates for the roles should exhibit the following skills and competencies:
• Experience in programming in SAS within the CRO/Pharma/Biotech/Healthcare industries
• Knowledge of statistics and exhibit routine and occasionally complex analytical skills
• A focus on quality, accuracy, and completeness of work activities
• Excellent communication skills
• A good understanding of Good Clinical Practice and ICH guidelines
• Ability to independently lead (or have lead potential) and estimate programming scope of work, handle resource assignments, communicate work status, and work within project timelines for deliverables
• Take initiative and can be counted on to get the job done, with integrity
• Have the self-awareness to recognize when negotiating skills and assistance are needed
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients

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Job Overview

• Supports and manages relationships with pharmacies in global clinical trials up to Phase III with a special focus on clinical trials conducted in the region
• Contact for IMP-related and Clinical Trial Supply Management (CTSM) -related questions for CROs/ Sites / pharmacies
• Contributes to training CROs and site personnel on IMP handling
• Liaises with GCP QA and supports CTSM GCP related activities
• Supports on appropriate CTSM GCP risk communication and ensures CTSM GCP requirements are met
• Manages complaints, deviations, changes, and other quality incidents for GCP topics
• Travel requirement: 15%

Qualifications

• Relevant professional experience (usually +3 years) in Clinical Supply or Clinical Research in Pharmaceutical/Biotech industry or CRO setting or any equivalent e.g., Pharmacy Services
• Relevant completed university education in Pharmacy, experience as a Clinical Pharmacist or in an equivalent role
• Deep understanding of country-specific requirement and standards for Clinical Trials conducted in the region
• Deep Knowledge about Pharmacy Manuals / Pharmacy Questionnaires
• Deep Knowledge about GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
• Business-professional English and local language skills
• Self-motivated with strong problem-solving and learning skills
• Ability to create independent analyses and develop new solutions
• Excellent organizational and communicative skills
• Enjoys working in a team
• Openness to explore on new topics for setting up the trend