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Senior Statistician - Italy - P

Employer
ClinChoice
Location
Italy
Salary
Competitive
Start date
2 Mar 2021
Closing date
1 Apr 2021

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Discipline
Data Management / Statistics, Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
CROMSOURCE has a rare opportunity to join its team in Italy as a Senior Statistician for an internal position.

The Senior Statistician is primarily responsible for performing statistical analyses of clinical studies and for providing statistical expertise when assessing study objectives, study design, randomization, analysis methods, endpoints and statistical power. The Senior Statistician may support the departmental management in organizing and executing the departmental activities.

The Senior Statistician applies good judgment and demonstrates initiative to resolve issues, whilst providing high quality statistical support.

Scope of the role:
  • Contribute to the development, implementation and maintenance of the quality system for Biometrics in general and biostatistics in specific, including process improvements and standards
  • Coaches and mentors other Biometrics team members and provides training to internal personnel and clients regarding statistical analysis of clinical studies
  • Provide high quality statistical support direct to our clients whilst managing projects, project staff. They may also be responsible for the development and line management of assigned personnel
  • Maintains an awareness of current up-to-date statistical/programming developments and regulations. Co-ordinates regular training sessions and ensures knowledge sharing and lessons learned are completed in a timely manner


Position Duties & Responsibilities:
  • Provides statistical and methodological input for sample size calculation
  • Provides statistical and methodological input for protocol development (including randomization, study design and sample size calculation) to ensure that the protocol reflects the GCP guidelines on biostatistics
  • Coordinates, prepares and performs set-up, testing/validation, documentation and filing of randomization deliverables, depending on the randomization system used
  • Reviews CRF, DVP, DMP and other applicable Data Management deliverables in order to support a high quality database
  • Develops or supervises the development of a detailed statistical analysis plan and related mock shells in order to pre-specify the statistical analysis according to the study protocol
  • Performs the statistical analysis of a clinical study in compliance with the analysis plan and protocol (including efficient programming of the inferential analysis, tables, listings and figures in SAS)
  • Leads the statistical analysis of a clinical study in compliance with the analysis plan and protocol (including efficient programming of the inferential analysis, tables, listings, figures and datasets, in SAS)
  • Performs a quality control review of the tables, listings, figures, datasets, inferential analysis and statistical text to ensure compliance with the protocol and SAP
  • Organizes/Leads a quality control review of the tables, listings, figures, datasets, inferential analysis and statistical text to ensure compliance with the protocol and SAP
  • Leads Data Review Meetings, including coordination of preparations and production of meeting report
  • Participates as Biostatistics member of DMCs as assigned on a per-study base as indicated , including coordination of preparations and production of meeting report
  • Files all datasets, computer programs and other material used in the preparation of the tables, listings, figures, statistical analyses and statistical text for the integrated study report in order to have a complete and transparent documentation of the whole process
  • Writes statistical reports and/or sections for the integrated study report, reviews the draft study report, ensures that all data presented is correct, that conclusions are consistent with the analyses performed and that the statistical part of the report is in accordance with regulatory guidelines
  • Takes responsibility for clear and effective communication with all internal and external parties involved in the clinical trials to allow for smooth and GCP compliant processes. Communicates effectively and openly with clients ensuring their needs are met
  • Manages projects, understands project scope, efficiencies, milestones and budgets, ensures the project team understand project scope and minimize issues that impact on the project team, whilst ensuring tasks are appropriately delegated and completed according to CROMSOURCE SOPs
  • Understands project scope, efficiencies, milestones and timelines
  • CDISC: Expert person, central reviewer of ADaM datasets, deliverables and processes, keeping abreast with all regulatory developments within CDISC


Education, Experience and Skills:
  • Master in sciences with substantial statistics component
  • At least five years of experience as a statistician in life science/pharmaceutical environment
  • Proven organizational and problem solving/decision making skills
  • Proven project management skills
  • Expert knowledge of the applicable regulatory guidance
  • Good proficiency in SAS software
  • Good proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Fluent in English and local language(s)
  • Good computer knowledge
  • Good communication skills


Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002479

or please contact Myna.Yeboah@cromsource.com for more information.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Senior Statistician, Statistician
Skills: biometrics, Biostatistics, CDISC, MS Office, SAS, Statistics Location: Italy Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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