Principal Statistical Scientist

Quintiles Transnational Corp. helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Quintiles helps its customers compress the time it takes to bring a drug from discovery through regulatory approval; accelerate the launch of products to peak sales, build effective sales forces and manage product portfolios more efficiently; and achieve strategic and financial objectives by offering tailored alternatives to traditional fee-for-service product development and commercial services agreements. Headquartered near Research Triangle Park, North Carolina, Quintiles was founded in 1982 and has more than 15,000 employees and offices in over 40 countries.

Principal Statistical Scientist -- Job #8547

Quintiles has an exciting opportunity for a Principal Statistical Scientist to work in our Kansas City, MO location. This individual's day to day responsibilities will include providing biostatistical oversight on one or more project teams as lead biostatistician on one or more large or multi-protocol projects. Candidate will be responsible for communicating with clients regarding study protocol or major statistical analysis issues and may represent clients with FDA. Additional responsibilities include interpretation of complicated analyses and writing statistical sections of study reports. Candidate may serve as Project Manager on more than one small, or one large, Statistical Operations project and may provide mentorship to other biostatisticians in the department. Candidate may participate as a lead as lead biostatistician on single or multi-protocol project(s) providing the following functions: a) develop statistical methods sections of protocol; review of CRF; b) develop analysis plans and may develop AROs; c) may coordinate with Medical Operations team members in development of Annotated Report Outlines (ARO); d) may develop specifications for tables, both for individual studies and in preparation of major regulatory documents, such as, IND, NDA, BLA and PMA; review output and tables; e) ensure efficiencies and consistencies across studies (or across NDA components, as appropriate). Additional responsibilites include:
*Interpreting complicated analyses and write statistical and/or joint clinical and statistical study reports, as well as ISE, ISS, and Section 10 components of NDAs.
*Interacting with clients on projects; leading biostatistics discussion at client meetings.
*Designing approach to projects with general supervision.
*Conducting complex statistical analysis utilizing SAS and other statistical software packages, as required.
*May serve as Project Manager as needed on Statistical Operations project.
*Represent clients with FDA; leads discussion when interacting with FDA on client projects.
*Maintain knowledge and awareness of developments in biostatistical methodology relevant to Phase I-IV clinical trials; provide biostatistical consultancy on complex statistical issues, and mentorship, to other biostatisticians in the department.
*Provide statistical training to department on complex analyses to assist in staff professional development.
*Participate as expert reviewer on deliverables for any projects, as needed.
*Produce sample size estimates and/or power calculations in complex situations.
*May oversee the preparation and submission of the statistical components of major FDA regulatory documents.
*Provide biostatistical input to clinical development plans.
*Give presentations to potential new clients.
*Perform short-term administrative and technical functions assigned by the Director (or supervisor), including participating in task forces and giving presentations to the Biostatistics staff or other departments.
*As approved, prepare manuscripts for publication and give talks at professional meetings.
*Excellent written and oral communication skills including grammatical/technical writing skills
*Advanced knowledge of complex statistical methods that apply to Phase I-IV clinical trials
*Strong organizational and leadership skills
*Ability to lead projects and/or individuals
*Familiarity with PC and VAX computing systems
*Strong working knowledge of SAS, familiarity with other packages, e.g., S+, SUDAAN, StatXact
*Proficient at solving complex scientific problems (identify, propose & implement solutions)
*Ability to lead teams within department and influencing interdepartmental team activities
*Initiative in expanding into new technical areas or expanding in-house technological capabilities in a given area
*Strong commitment to teamwork and quality
*Extensive experience in FDA interactions
*Working knowledge in FDA guidelines relating to statistical analysis, study reports, and statistical components of NDAs/BLAs
Preferred candidate will have a PhD. degree in Statistics or Biostatistics and 8 years working biostatistical experience in the clinical trials environment; or equivalent combination of education, training and experience. If this sounds like you, please apply!


Various compensation and benefits programs are available depending on position, years of experience and geographic location. Many of the benefits of working with Quintiles Transnational Corp. go beyond financial remuneration and include continuous on-the-job training, company recreational events, and community support activities. Quintiles is an Equal Opportunity Employer M/F/D/V. No agency referrals please.

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