Head of Data & Statistical Sciences
|Job Title:||Head of Data & Statistical Sciences|
|Salary:||US$200000.00 - US$225000.00 per annum|
|Contact Name:||Tim Tirabassi|
|Job Published:||January 12, 2018 04:23|
The Head of Data and Statistical Sciences is part of the Global Medicines Development (GMD) department. This Department is responsible for the end to end clinical development of new compounds for the treatment of addictions and related issues. This role will sit on the Global Medicines Development Leadership Team.
The Head of Data and Statistical Sciences will be accountable for leading a group of statisticians, statistical programmers, and data management experts. Together, this platform function is accountable for supporting all studies with GMD accountability, as well as supporting the clinical development strategy and execution of such within the clinical development plan.
Accountable for the development of the Data and Statistical Sciences strategy for every asset within the portfolio.
Responsible (with the Heads of Early and Late-Stage Global Clinical Dev) for study design, concept protocols and data analysis strategy for all studies, ensuring use of PK/PD, safety, translation medicine and pre-clinical data and ensuring clear understanding of regulatory requirements throughout.
Accountable for ensuring that all critical data and statistical sciences issues are brought to the attention of the Senior Vice President, Global Medicines Development and that programmes and projects are adequately resourced.
Responsibility for clinical standards, SOPs, discipline, excellence and appropriate timelines for Data and Statistical Sciences activities
Contributes to provisions of expert scientific and clinical review and approval of key documents such as Clinical Investigator Brochure (CIB), INDs, CTX/CTAs, NDAs and publications in biomedical/scientific journals in collaboration with project team and relevant cross functional colleagues.
MSc or PhD in Biostatistics
10+ years in the Pharma drug development experience are required within biostatistics and/or data sciences
Successful line management and/or matrix management experience required
Clear understanding of technical aspects relevant to early drug development in pharma industry
Knowledge of global regulatory requirements as they relate to requirements for approval for new medications in the US, EU, CAN, EMAP, China.
Lawrence Harvey is acting as an employment agency in regards to this position.
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