Chiesi Pharmaceuticals Open Work Positions – Search for a “Senior Statistician” and two “Lead Statistical Programmers”
Chiesi Farmaceutici is looking for three figures to be included in its staff, specifically is looking for a Statistical Nior and two Lead Statistical Programmer, below the selection criteria.
The selection will be entrusted to the company IQVIA (www.iqvia.com).
To apply for the desired position, simply connect via the Linkedin Platform.
SENIOR STATISTICIAN – Click here to apply
Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry – in order to expand their staff, entrusted to IQVIA the recruitment of a Senior Statistician who can join an exciting working environment in a dynamic and international 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
LEAD STATISTICAL PROGRAMMER – Click here to apply
Our client, Chiesi Farmaceutici – one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry – in order to expand their staff, entrusted to IQVIA the recruitment of a Lead Statistical Programmer who can join an exciting working environment in a dynamic and international atmosphere.
RESPONSIBILITIES:
• 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
• 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