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Quintiles

**GFR Senior Biostatistician/ Biostatistician 2 - Based Europe

When you work for Quintiles you work for the world’s leading Pharmaceutical Services Company. We offer product development and commercialisation services to the Pharmaceutical, Biotechnology and Medical Devices industries. Our leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the market place more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision. Of the world’s top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one.

PURPOSE

Develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. Interpret analyses and write statistical sections of study reports. Provide training, guidance and mentorship to lower level and new staff.

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RESPONSIBILITIES

Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.

Perform protocol development, sample size calculation, protocol and CRF review.

Advise data management staff on database design, and critical data. May advise on validation checks.

Write statistical sections of integrated reports.

Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).

Act as statistical team lead for single complex studies or groups of studies.

Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.

Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.

Manage customer relationships.

Provide training and guidance to lower level and new staff.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Excellent written and oral communication skills including grammatical/technical writing skills
  • Excellent attention and accuracy with details
  • Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
  • Strong individual initiative
  • Strong organizing skills
  • Strong working knowledge of SAS computing package
  • Familiarity with other statistical computing packages such as S , SUDAAN, StatXact
  • Strong commitment to quality
  • Ability to effectively manage multiple tasks and projects
  • Ability to provide and accept direction of lead team members
  • Ability to solve moderately complex problems
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • PhD in biostatistics or related field; Master’s degree in biostatistics or related field and 1 year relevant experience; Bachelor’s degree in biostatistics or related field and 2 years relevant experience; or equivalent combination of education, training and experience

At Quintiles we value individuality, fresh ideas, and the contribution that our employees make to our success. In return we offer career opportunities providing flexibility and growth across the organisation, covering multiple locations to suite your lifestyle requirements at this time, a competitive salary and a fantastic benefits package.

If you want to make a difference in global healthcare, Quintiles is the place for you. It’s work worth doing.

Job ID: 921f35ec64466363847bc46722f79eb4
Employment Type: Other

This job is no longer available.

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