Director/Senior Director & Biometrics Team Leader – Diabetes & Metabolic Diseases (DMD) - Gaithersburg, MD | Biospace
Get Our FREE Industry eNewsletter

Director/Senior Director & Biometrics Team Leader – Diabetes & Metabolic Diseases (DMD)

AstraZeneca Pharmaceuticals LP

Apply
Location:
Gaithersburg, MD
Posted Date:
7/27/2017
Position Type:
Full time
Job Code:
R-007868
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Location:Gaithersburg, Maryland, United States
Gothenburg, Västra Götaland, Sweden
Job reference: R-007868

Posted date: Jun. 28, 2017



At AstraZeneca we work together across global boundaries to make an impact and find
answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing.

Within GMD, AstraZeneca’s Biometrics and Information Sciences (B&I) group are looking for a talented and experienced Director & Biometrics Team Leader to work within the Diabetes & Metabolic Diseases (DMD) team.

As a Director and Team Leader in B&I – the home of late stage biometrics at AstraZeneca – you will build on your existing experience and knowledge in statistics to play a crucial role delivering the d
iabetes & metabolic diseasesdrug portfolio.

Our TA aligned Statistics group oversees and delivers all the statistical and programming contribution to design, decision-making, interpretations and communication (internally and externally) for portfolio of projects in the TA portfolio and is engaged in shaping the TA external environment.

As part of the Statistics community you will join some of the most respected Statistics experts in the industry, focused on outstanding program design and delivery of the quality information we need to meet our drug project objectives driving clinical 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 Gaithersburg, US or Gothenburg, Sweden.

Core accountabilities & responsibilities:

You will be reporting to the B&I TA Head and your responsibilities include:

  • To lead, manage and develop a group of statisticians
  • Leadership to B&I staff on the product world-wide so that all work is carried out with regards to AZ standards and external regulations
  • To lead the strategic and operational planning of the B&I contributions to the Development Plans, Regulatory Strategy and Submissions, Health Technology Assessment and Commercial support of AZ products
  • Lead regular Biometrics Team meetings for optimal communication
  • Provide clarity on team member responsibilities to CPT, GPT, AZ governance and Health Authority interactions to maintain accountability thread through TA Head
  • Ensure Information Exploration Team is in place to deliver and document Ad-hoc work.
  • Developing design options and providing high quality decision support
  • Quantifying the Benefit, Risk, Value and Uncertainty of the emerging product profile
  • Setting the standards (and enforcing compliance) for statistical work
  • Holding CRO/Partners accountable for the high quality standards of their deliverables
  • Represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specificprojects/indications;
  • Investigate and implement statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
  • Maintains understanding and awareness on new methodologies, therapy area and Development initiatives
  • Provide leadership and direction to improvementprojects/activities/initiatives
    and drive the implementation of best practice across the group.
  • Develops contacts with international opinion leaders, consultants and collaborative groups
  • Ensure drug projects are successfully delivered in terms of scientific leadership and resourcing

Requirements

Essential Requirements

  • Leadership Capabilities @Level 3
  • MSc/PhD in Statistics orMathematics (containing
    a substantial statistical component) with experience in pharma/healthcare or other relevant area
  • In depth knowledge of the technical and regulatory requirements related to the role
  • Extensive experience of Development, program design, data analysis and interpretation
  • Experience of regulatory interactions and/or submissions
  • Managerial experience
  • Excellent communication skills and ability to build strong relationships
  • Excellent collaboration required – needs the energy to work across global & functional boundaries both internally and externally
  • Ability to apply statistical expertise to complex problems, problem solving and quality focus
  • Diabetes, CVOT (Cardio-Vascular Outcome Trial) &/or Heart Failure experience preferred