• United States Of America, Usa
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  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

At AstraZeneca we turn ideas into life changing medicines Working here means being entrepreneurial, thinking big and working together to make the impossible a reality We are currently seeking an experienced Statistician to join AstraZeneca Cardiovascular, Diabetes and Metabolic function, either at the level of Principal Statistician, or at Statistical Science Lead

As a Statistician in Biometrics & Information Sciences (B&I) - the home of late stage biometrics at AstraZeneca you will build on your existing experience and knowledge in CVRM (Cardio Vascular, Renal Medicine & Metabolic Disease) statistics to play a crucial role delivering one of the most exciting drug portfolios in the industry

Our Therapeutic Area aligned Statistics groups oversee and deliver the statistical contribution to design, decision-making, interpretations and communication of the Therapeutic Area portfolio and is engaged in shaping the external environment

Location can be in Gothenburg - Sweden, Cambridge UK or Gaithersburg - US

As Statistical Science Lead you will lead the statistical contribution and statistical design of drug project teams on projects transitioning into late phase development, products in Phase III development or in Established Brand teams in lifecycle development

You will play a key role formulating the go/no decisions at the end of Phase II, in planning the product development, strategies, ensuring effective design and delivery of studies and submissions, interpretation and communication of results, in strong collaboration with external partners and support value demonstration and commercialisation of the product including Health Technology Assessment (HTA), and global publication team activities Our Statistical Science Leads provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies

Main Duties & Responsibilities

To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation of AZ products
Leadership to statistical staff on the product world-wide so that all work is carried out with regards to AZ standards and external regulations
Through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions
Quantifying the benefit, risk, value and uncertainty of the emerging product profile
Setting the standards (and enforcing compliance) for statistical work within the product;
Holding CRO/Partners accountable for the high quality standards of their deliverables;
Represents AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications;
Promote, investigate, develop and implement novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration
Develop relationships with international opinion leaders, consultants and collaborative groups

Essential Requirements

MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
Proven and in depth experience in pharma/healthcare or other relevant area
In depth knowledge of general and therapeutic area statistical methodology and regulatory requirements related to the role (Cardiovascular, Renal Medicine and Metabolic disease TA knowledge is preferred)
Extensive experience of Development, programme design and data analysis and interpretation
Substantial experience of regulatory interactions and/or submissions
Strong Leadership experience

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : IT Software : Software Products & Services
Role : Quality Assurance/Testing
Salary : As per Industry Standards
Deadline : 11th Apr 2020

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