Quintiles is the only fully integrated BioPharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of 23,000 engaged professionals in more than 50 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com. Various compensation and benefits programs are available depending on position, years of experience and geographic location. Many of the benefits of working with Quintiles go beyond financial re-numeration and include job related training, company recreational events, and community support activities.

Quintiles is an Equal Opportunity Employer M/F/D/V.


Sr Biostatistician

Location: Overland Park, KS 66202

Job Category: Biotech/R&D/Science

Career Level: Experienced (Non-Manager)

The Clinical Development Services division of Quintiles has more depth of therapeutic expertise and a broader range of services than any other service provider. We conduct both US and Global trials in all therapeutic areas.  In fact, Quintiles conducts more clinical trials than anyone else in the world.  Become involved in work that improves the quality of life for people around the globe.  Let your career soar! We are a seeking enthusiastic Senior Biostatistician.


 


The Senior Biostatistician will develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, consistency checks, 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.


 


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, validation checks and critical data.
• 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).
• Fulfill the Lead role for single complex studies or groups of studies.
• Manage project budget and resource requirements. Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies.
• Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.
• Manage customer relationships and provide training and guidance to lower level and new staff.



• PhD or educational equivalent in biostatistics or related field and 1 year relevant experience; Master's degree or educational equivalent in biostatistics or related field and 3 years relevant experience
• Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials
• Strong working knowledge of SAS computing package
• Familiarity with other statistical computing packages such as S+, SUDAAN, StatXact
• Pharmaceutical, drug development, biotech or CRO industry experience
• Excellent written and oral communication skills including grammatical/technical writing skills
• Excellent attention and accuracy with details
• Strong individual initiative, organization skills and multi-tasking ability.
• Ability to lead and co-ordinate small teams


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