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Lead Statistical Programmer

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Lead Statistical Programmer who can join an exciting working environment in a dynamic atmosphere.

JOB DESCRIPTION:


• To develop SAS programs and statistical output for the management and reporting of clinical trial data managed by GCD.
• To guarantee quality of statistical output produced by external provider, to program tools to support data review activities and data visualization, to collaborate on the interpretation and communication of trial results.
• To contribute to regulatory submissions, converting data according to regulatory requirements, preparing integrated analyses and related documentation.
• To perform post-hoc analysis for exploratory purposes, or to support regulatory requests, to prepare analysis for paper publications.
• To support the development of standard operating procedures


RESPONSIBILITIES:


• To convert data to CDISC SDTM, following project specifications • To develop SAS programs to generate analysis datasets (CDISC compliant)
• To produce datasets documentation according to CDISC and FDA requirements (define.xml) and/or to review analysis datasets documentation prepared by providers
• To develop SAS programs to produce tables, listings, and figures as planned in the statistical analysis plan and to support data review activity before database lock
• Develop SAS macros and SAS programs for data quality evaluation and to develop data quality reports
• Writing, documenting, and performing quality control review of SAS programs
• To perform ad hoc analysis for various statisticians’ requirements
• To support statisticians in the preparation and/or review and QC of statistical package for FDA submissions
• To perform QC of the programming material prepared by external providers guaranteeing the output provided is correct and in line with International requirements and with internal SOP/Standards


REQUIREMENTS AND SKILLS:


• Good experience in SAS
• Proficient in Macro Facility
• Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to Standard Operating Procedures (SOPs).
• Knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM), Analysis Dataset Models (ADaM), Operational Data Model (ODM) and Case Report Tabulation Data Definition Specification (Define.xml).
• General knowledge of statistical methods
• Have excellent analytical, problem solving, communication and interpersonal skills
• Effective verbal and written communication skills
• Strong commitment to quality
• Ability to work in a team-based environment



TYPE OF CONTRACT:


Long Term contract – Staff Leasing

E-mail: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.


IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

Senior Data Manager

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Senior Data Manager who can join an exciting working environment in a dynamic atmosphere.

JOB DESCRIPTION:


• To ensure data management activity of the assigned studies are planned and executed according to project timelines, with highest standards in data integrity, data quality and under budget control
• To ensure technologies/systems/data platforms needed for collecting and handling clinical data are properly developed, tested, fit for purpose and integrated
• To support the definition of the strategy for data submission and lead the preparation of the data package to be submitted for drug approval
• To represent Data Management in case of audit and Regulatory Inspection


RESPONSIBILITIES:


• To plan and drive the conduct of all Data Management activities for the assigned studies ensuring consistency with Company standards and regulatory guidelines
• To provide data management input and revision to study protocols
• To design/review mock CRF/eCRF contents ensuring consistency with Study Protocol
• To manage and guide providers, setting requirements, preparing the Request for Proposals and monitoring performance
• To ensure all data collection systems for assigned studies are setup, tested and fit for purpose according to expectations and timelines
• To review and approve CROs data management study documentation: Data Management Plan, database and data validation specifications, data transfer specifications, data reconciliation plan
• To collaborate in the definition of Protocol Deviations Plan and monitoring of protocol deviations during the study conduction
• To train or to provide consultancy to internal stakeholders on data management processes/standards/usage of tools (i.e. UAT, EDC tools, etc…)
• To assist coding of medical terms and medical review
• To ensure data cleaning is performed by CROs in according to data validation specifications by the revision of appropriate listings or data quality checks
• To review database structure, annotated CRF and define.xml to ensure CDISC standards are properly implemented
• To define and proactively manage risks with potential impact on study systems setup, study conduction, or reliability of study results, including contribution of definition of Quality Tolerance Limits and Key Risks Indicators
• To lead the data quality evaluation, by the investigation of all clinical and operational data, evaluating trends, deviations, using visual analytics tools and ad hoc reports
• To coordinate cross-functional data review meetings managing the collection of data issues, reporting of findings and communication of post-review status
• To ensure database are locked according to regulatory requirements
• To regular monitor data management costs of the assigned studies ensuring respect of budget
• To ensure audit readiness and involvement in the CAPA process • To lead the preparation of data package for regulatory submission
• To contribute to lessons learnt meeting at the end of the study, providing inputs to data handling procedures


REQUIREMENTS AND SKILLS:


• University Degree in Scientific Disciplines
• Minimum 5 years of experience in Clinical Data Management in CROs or Pharmaceutical Industry
• Good knowledge of drug development processes
• Good data management expertise
• Solid knowledge of Good Clinical Data practices, GCP and regulatory requirements
• Experience of clinical databases, electronic data capture (EDC) systems, Interactive Response System, ePatient Reported Outcome (ePRO), and wearables and sensors to collect data directly from patients
• Good knowledge of Risk-Based approach
• Knowledge of Real Word data sources and processes to collect/manage different type of sources (e.g. EHR data, data collected directly from patients, omics data, other secondary data)
• In depth knowledge of Clinical Data Interchange Standards Consortium (CDISC) relating to data standards including Study Data Tabulation Model (SDTM) and Case Report Tabulation Data Definition Specification (Define.xml)
• Advanced analytical and technical skills to interrogate and mine high volume of data from a variety of sources
• Basic knowledge of Artificial Intelligence (AI)
• English


TYPE OF CONTRACT:


Long Term contract – Staff Leasing
E-mail: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

Senior Statistician

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Senior Statistician who can join an exciting working environment in a dynamic atmosphere.

JOB DESCRIPTION:


Provide statistical expertise and contributions for projects and protocols in support of Drug Development Programs; provide statistical expertise on regulatory submissions and ensure quality and appropriateness of submission deliverables; provide/oversee statistics support to clinical trials, ensuring that data are collected, analyzed and evaluated with statistical rigor.


RESPONSIBILITIES:


• Provides statistical input in support of Drug Development Programs
• Provides statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results
• Interacts with CROs and supervise statistical activities
• Reviews/Develops the Statistical Analysis Plan, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports
• Plans and conducts statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies
• Conducts all the statistical activities for the Blind Review Meeting
• Reviews the Clinical Study Report
• Collaborates in writing regulatory document, reviews sections of regulatory submissions, attends meetings with regulatory agencies to support drug registration
• Manages the statistical deliverables required by eCTD submission
• Reviews abstracts, posters, presentations for publication
• Contributes to definition of SOPs


REQUIREMENTS AND SKILLS:


• University Degree Statistics
• A significant experience in clinical statistics
• Capability to provide statistical leadership to cross-functional teams at the protocol level
• Strong statistical skills with application to clinical trials
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Demonstrated professional experience in pharmaceutical industry work, e.g., clinical trial design and analysis, regulatory submissions, product defense, publications, and marketing support.

• Verbal Communication
• Teamworking
• Problem Solving
• Decision Making
• English knowledge


TYPE OF CONTRACT:


Long Term contract – Staff Leasing

E-mail: Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.


IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

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