Strategic Biostatistics Director Late Phase Job
Job Code - 1114892
Position - FULL TIME
Job First Active on: Tuesday, October 25, 2011
Strategic Biostatistics Director (Late Phase)
When you work for Quintiles you work for the world's leading Pharmaceutical Services Company. We offer product development and commercialization 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 commercialize every single one.
We have an opportunity for a Senior Strategic Biostatistics Director to provide strategic statistical and epidemiological/outcomes research input to high-priority Late Phase sales opportunities to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of product commercial success through appropriate management of risk and value demonstration. Represent Quintiles externally with healthcare stakeholders (FDA, EMEA, Payers, Insurers etc) and actively pursue thought leadership opportunities.
* Provide strategic statistical and epidemiological/outcomes research input to Late Phase sales opportunities to help increase revenue, with emphasis on methods to cut costs, decrease time, or increase chance of product commercial success through appropriate management of risk and value demonstration.
* Provide strategic biostatistical and epidemiological/outcomes research consultancy to customers on a billable basis
* Maintain knowledge and awareness of developments in biostatistics, epidemiology and outcomes research. Carry out new developments in areas of statistical design or analysis that can be used to give Quintiles a greater edge over competing CROs.
* Market Quintiles' statistical and epidemiologic/outcomes research expertise, may include:(i) publishing papers that demonstrate expertise in key areas (such as risk management, health economic assessment); (ii) giving presentations at conferences, particularly those attended by key decision makers for outsourcing high value business; and (iv) contribute to publicizing internally to key groups.
* Actively network in the industry to establish relationships and to identify potential opportunities.
* Deliver/oversee billable services to customers aligned with domain expertise
May oversee and participate in the provision of training to internal Quintiles staff
REQUIREMENTS - QUALIFICATIONS: Strategic Biostatistics Director (Late Phase)
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Extensive and moderately in-depth knowledge of many of those complex statistical analysis methods that apply to Phase IIIB/IV clinical trials and prospective observational research, which can be used to cut time, cut costs, and/or increase chance of success
• Good overview knowledge of many of the new and cutting-edge design and analytical approaches that can beneficially be applied to Phase IIIB/IV clinical trials and observational studies
• Ability to develop new methods to cut costs, decrease time, or increase success for marketed drugs
• Moderately high level of knowledge of current guidelines with respect to pragmatic trial and observational study designs, endpoints, and acceptable analyses for multiple therapeutic areas
• Good understanding of peri- and post-approval research needs
• Knowledge of SAS
• Excellent written and oral communication skills
• Strong negotiating skills
• Ability to operate simultaneously across numerous projects
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
· MSc or PhD in Epidemiology or closely-related discipline
· CRO/consulting and pharma experience
· Observational research/registry and Patient Reported Outcomes (PRO) experience
· Active externally with professional bodies/academic groups
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 organization, covering multiple locations to suit 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.
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