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Manager Statistics / Principal Statistician - RTP, North Carolina Stockley Park, Southwest England [01/20/2010] |
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Basic qualifications:
MSc or PhD in Statistics (or equivalent). Extensive experience working as a statistician with clinical pharmacology/pharmacokinetic (PK) studies in a Phase I-IV setting. Experience should include study design, sample size calculation, statistical analysis and reporting of clinical pharmacology/PK studies, input to protocol development, clinical study reports and publications. Should have knowledge regarding regulatory requirements for clinical pharmacology/PK studies to support global regulatory submissions. Experience with contributing to preparation and review of regulatory documents for clinical pharmacology sections of submissions and interacting with regulatory agencies. Should have experience of collaboration with pharmacokineticists in the design, analysis and reporting of PK data collected in Phase II/III safety and efficacy trials.
Knowledge of and experience with crossover designs, repeated measures analyses, analysis of mixed effects models (linear and nonlinear).
Experience with PK and PK/PD data analysis, exploratory analyses of PK and PK/PD data to support internal decision making and submissions to regulatory agencies. Experience with collaborating with clinical pharmacologists, pharmacokineticists, pharmacometricians and clinical statisticians in defining and conducting exploratory PK/PD analyses with PK data across Phase II/III studies to support key safety and efficacy results.
Experience in working with Project Teams, with a proven track-record of strong technical, organisational, and communication skills, with the ability to work independently and multi-task. Strong leadership skills and a demonstrated ability to make an impact within a cross-functional team in support of complex projects. Experience in collaborating with pharmacokineticists and clinical pharmacologists and with external interactions such as with advisory boards, consultants, investigators. Experience with researching and applying innovative designs and analyses. Preferred qualifications:
Specific experience with clinical pharmacology/PK studies in the Neurosciences therapeutic area. A demonstrated ability to lead a group of statisticians and/or statistical programmers and to work effectively with external stakeholders is desirable. Experience with Bayesian and adaptive designs and analysis, nonlinear mixed effects modelling and knowledge of software such as WinBUGS, R and S-Plus, NONMEM, TRIAL SIMULATOR, is desirable.
As the workload specifically aligned with clinical pharmacology / PK studies is hard to predict, experience with more traditional Phase II-IV clinical trials is also desirable. Details:
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development at UK and US sites. The current vacancy is for an experienced statistician to join a team based either at RTP, NC, US or Stockley Park, UK.
The specific opportunity will depend on the individual’s qualifications, but could range from supporting a long-established marketed asset to providing support for a Phase II new chemical entity. The role includes working closely with UK- and US-based colleagues across a range of disciplines to plan clinical pharmacology/pharmacokinetic designs and to define and conduct appropriate analyses to support regulatory, reimbursement, and commercialisation needs.
The individual will work closely with project clinical pharmacologists, clinical statisticians and pharmacokineticists to ensure study designs and analyses are in alignment with project strategies and objectives.
Depending on level of experience, the role may include direct interaction with external stakeholders, so communication and influencing skills are important. Job Type: Contract/Temp Location: Jobs Site Search
Salary: [n/a] Date available: now Specialist Industry: Statiscal Analysis Company: GlaxoSmithKline Company Description: We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer. This mission gives us the purpose to develop innovative medicines and products that help millions of people around the world.
We are one of the few pharmaceutical companies researching both medicines and vaccines for the World Health Organizations three priority diseases HIV/AIDS, tuberculosis and malaria, and are very proud to have developed some of the leading global medicines in these fields.
Headquartered in the UK and with operations based in the US, we are one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market.
But being a leader brings responsibility. This means that we care about the impact that we have on the people and places touched by our mission to improve health around the world.
It also means that we must help developing countries where debilitating disease affects millions of people and access to life-changing medicines and vaccines is a problem. To meet this challenge, we are committed to providing discounted medicines where they are needed the most.
As a company with a firm foundation in science, we have a flair for research and a track record of turning that research into powerful, marketable drugs. Every hour we spend more than £300,000 (US$562,000) to find new medicines.
We produce medicines that treat major disease areas such as asthma, virus control, infections, mental health, diabetes and digestive conditions. In addition, we are a leader in the important area of vaccines and are developing new treatments for cancer. Company Website: [n/a]
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05/16/2012