Principal Statistician/Statistical Science Director – Diabetes and Metabolic Disease – Gothenburg, SE or Gaithersburg USA - Gaithersburg, MD | Biospace
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Principal Statistician/Statistical Science Director – Diabetes and Metabolic Disease – Gothenburg, SE or Gaithersburg USA

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
5/24/2017
Position Type:
Full time
Job Code:
R-003114
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gothenburg, Västra Götaland, Sweden
Gaithersburg, Maryland, United States
Job reference: R-003114

Posted date: May. 05, 2017

                                                     
                           


 

   Principal Statistician/Statistical Science Director – Diabetes and Metabolic Disease – Gothenburg, SE or Gaithersburg USA  

   We are currently seeking experienced Statisticians to join AstraZeneca. Either at the level of Principal Statistician or Statistical Science Director.  

   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 have immediate opportunities in our core Therapy Area: Diabetes and Metabolic Disease (DMD). Appointment to this position will be at the level consistent with the successful candidate’s skills and experience.  

   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 DMD statistics to play a crucial role delivering one of the most exciting drug portfolios in the industry.  

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

   Our Statisticians provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies. Statisticians may also lead strategic capability or business area improvements within the Department. Our DMD statisticians also have access to support from our Advanced Analytics Center which houses our statistical innovation, modelling and simulation and design expertise.  

   As part of the Statistics community you will join some of the most respected Statistics experts in the industry, focused on outstanding programme design and delivery of the quality information we need to meet our drug project objectives that drives product development.  

   B&I drives good design to generate the data needed for quality decision making. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.  

   Successful candidates will be located in Gothenburg, Sweden, one of AstraZeneca's key strategic science centres.  

   Main Duties & Responsibilities:  

 

   Principal Statistician  

 

   As a Principal Statistician you will deliver global submissions and have opportunity to be indication lead on crucial elements of our pipeline.  

 
       
  •      To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.    
  •    
  •      Leadership to statistical staff on the indications/projects 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.    
  •    
  •      Holding CRO/Partners accountable for the high quality standards of their deliverables;    
  •    
  •      Represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications;    
  •    
  •      Application of expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.    
  •    
  •      Mentor/coach and support the education and training of Statistics staff in the technical arena.    
  •  

   Statistical Science Director  

 

   Reporting to a Biometrics Team Leader, who is accountable for the entire Biometrics contribution to a project, 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 Directors provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies.  

   Statistical Science Director contributions are:  

 
       
  •      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.    
  •    
  •      Mentor/coach and support the education and training of Statistics staff in the technical arena.
  •  

Requirements

   Essential Requirements  

 

   Principal Statistician  

 
       
  •      MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area    
  •    
  •      DMD experience desired or experience using similar methods applied to DMD.    
  •    
  •      Knowledge of the technical and regulatory requirements related to the role    
  •    
  •      Experience of Development, programme design and data analysis and interpretation    
  •    
  •      Experience of regulatory interactions and/or submissions    
  •    
  •      Excellent communication skills and ability to build strong relationships    
  •    
  •      Leadership role able to lead and direct elements of project work    
  •    
  •      Accountable for the statistical work within the project    
  •    
  •      Report to Director and Biometrics Team Leader
  •  
 

   Statistical Science Director  

 
       
  •      MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area    
  •    
  •      5+ years’ 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 (Diabetes 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.    
  •    
  •      Excellent communication skills and ability to build strong relationships    
  •  

   Welcome with your application no later than April 30, 2017.  

 

   Interviews will be held continuously, apply now.  

   AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status or any other characteristic protected by law.