Quintiles organization has more depth of therapeutic expertise and a broader range of services than any other service provider. We support both US and Global trials in all therapeutic areas. In fact, Quintiles supports 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!
Quintiles is seeking an enthusiastic Senior Biostatistician/Biostatistician to join our U.S. Biostatistics Operations team. This is a homebased opportunity anywhere in North America.
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.
- 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
- Familiarity with SAS Drug Development (SDD) and Clinical Data Integration (CDI) would be preferred.
- 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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