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Principal Biostatistician

Employer
IQVIA
Location
Milan
Start date
8 Nov 2020
Closing date
6 Dec 2020

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Job Details

THE ROLE

IQVIA is looking to appoint Principal Statistician to coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.  

A Principal statistician will typically be involved in:

Main task/projects:

All statistical activities related to a complex Phase 3 design study (MACiTEPH), with interim analysis with Sample Size Reassessment estimation (SSRE). This will include writing and developing key statistical documents or contribute to the activities: IDMC charter, SAP, Data programming specifications, support for interim analysis, participation to the clinical trial team meetings, preparation of the IDMC meetings, protocol amendments, study start-up activities: randomization, ERT, adjudication committee and charter development, support to local and regional protocol submissions to ethic committees or HA.

Key requirements:

Knowledge and experience with adaptive studies (conditional power, SSRE), MMRM/mixed model, event-driven models, Phase 3 studies (clinical development), interaction with Health Authorities (EMA or FDA)

Preferred Therapeutic areas (one of these): Pulmonary Hypertension, Cardio-Vascular, Oncology

Statistical knowledge: MMRM, Cox Model and stratified log rank test, interim analysis with SSRE, use of conditional power.

Other skills:

Can manage multiple tasks, work independently in a multi-functional environment, take ownership and responsibility of the allocated tasks, good project management and communication skills.

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 PhD degree in Biostatistics or Statistics and relevant experience.  Key required skills include: 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:

  • Work experience in statistics
  • Ability to communicate and explain statistics
  • Exhibit routine and 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
  • Experience in programming in SAS for purposes of data review and statistical analysis
  • Ability to independently lead
  • Take initiative and can be counted on to get the job done, with integrity
  • 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

Embrace your curiosity and grow your career in an exciting environment where development is a priority. Think boldly and disrupt conventional thinking. Enjoy what you do. Discover a career with greater purpose and help create a healthier world.

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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