Statistical Science Director in Gaithersburg, MD

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Matthew Masterson
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Statistical Science Director in Gaithersburg, MD

 Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.

Description:

The main roles undertaken by the Statistical Science Director are Global Product Statistician (GPS), Statistical Expert and Delivery Team Leader. Statistical Science Directors provide highly experienced strategic, statistical support and leadership to product teams, specialised areas (e.g. patient safety, clinical pharmacology alliance, personalised healthcare), and the Statistics & Programming Department, in the creation of clinical development programmes to maximise the market potential of AstraZeneca products

Statistical Science Directors provide statistical consultancy and set statistical standards within Global Statistics and Programming. They have an external focus and a positive image through attending meetings, and producing publications.

The area of focus of the key roles differ by area of speciality and below there is more specific information on the requirement and accountabilities for each area of specialisation

In particular GPS:

The GPS provides statistical leadership, expertise, and strategic thinking to the design and interpretation of AstraZeneca drug development programmes. The GPS is the expert statistical leader for a compound/product or series of compounds/products which are either approaching development (Clinical Discovery), in development or in the Post-marketing phase. The GPS is accountable for providing strategic, scientific expertise to quantify the Benefit, Risk, Value and Uncertainty (BRV(U)) of the emerging product profile throughout the lifecycle of the drug development process. They lead the statistical thinking for all aspects of the development process including development of TPP/TPC, BRV(U), Brand Business Plan, Clinical Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Exploitation of AZ products. They are accountable for the Statistical work on the product world-wide and represent AZ and Statistics to Health Authorities

In particular Statistical Experts:

The Statistical Expert is a global role that provides strategic input and scientific and statistical leadership to the development, delivery, and continuous improvement of quantitative sciences applied to drug development within their appointed area of expertise/focus. They set the relevant scientific and operational standards and ensure that they are met for their area of expertise/focus, which includes the development and implementation of best practices. They provide strategic, scientific and statistical expert advice and active leadership to relevant management and leadership figures/teams (eg, TACVP, PS Directors, CSE, GPT, CPA Medical and Scientific Advisory Board, HELC, S&I leadership team) as well as to other members of the clinical teams (eg, GPS, MSD, CPTs, SaMT, SKG).

Accountabilities/Responsibilities:

GPS

* The GPS is accountable for providing strategic, scientific expertise to quantify the benefit, risk, value and uncertainty of the emerging product profile throughout the lifecycle of the drug development process.
* The GPS is accountable for leading the statistical thinking and contributions to the creation and development of TPP/TPC, BRV(U), Brand Business Plan, Clinical Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Exploitation of AZ products. The GPS' activities and accountabilities include the following:
* Expert at utilising a broad range of experts (eg, Informatics, Modellers, Safety Statistics, external experts) and integrating their input and expertise in the development and characterization of design options
* Developing design options that address cost, time, uncertainty and probability of success, with the appropriate use of modelling and simulation or other techniques to enable the business to make informed decisions
* Partnering and collaborating with relevant expert functions (eg, HEOR, CPD and medics) in all quantitative questions
* Delivering high quality decision support to all investment decisions (well documented, comprehensive but not excessive, leading to unambiguous decisions)
* Statistical support to the development of the regulatory strategy, appropriate messaging of scientific and statistical issues and defence of marketing applications
* Statistical support to the value demonstration and commercialisation of the product, including Health Technology Assessment (HTA), Patient Reported Outcomes (PRO) utilisation, and the global publication team activities
* Long- and short-term contingency planning to support the Clinical and Global Product Teams
* Input to risk management and mitigation strategies for the product
* Input to issues management team activities.

* Expert statistical leadership to the Design and Interpretation Working Group (core member) and to the GPT and CPT.
* Ensure efficient and effective leadership and management of project information, strategy, quality standards, and integrity of information interpretation.
* Accountable for the statistical work on the product worldwide and for leadership to the internal and external statistical staff world-wide assigned to the compound/product
* Setting the standards (and enforcing compliance) for statistical work within the product;
* Providing a framework for and ensuring statistical consistency to all development deliverables for a product;
* Ensuring quality design, statistical specifications, and interpretation
* Specification of all quantitative output, based on clinical study data, in Clinical, that it is comprehensive but not excessive and cost-effective
* Holding CRO/Partners accountable for the high quality standards of their clinical and statistical deliverables;
* Working with line management and project leaders to support the development of staff assigned to their projects and to assist with the planning of Statistics resources to deliver on project objectives.

* Represents AZ and Statistics to Health Authorities worldwide;
* Provide support the wider scientific development of the product;
* Network with colleagues and experts, providing statistical consultancy in own area of expertise and serving as a resource for others by sharing experience within and beyond project team and Statistics function.
* Identify options and opportunities for innovative thinking and approaches to improve quality, cost or time and where appropriate lead the development of new methodology or process to provide business benefit
* Negotiation of time frames for statistical project activities.

Statistical Expert

* To provide a expert statistical review and consultancy across all the drug projects within their area of expertise to ensure that clinical development programs (or parts assigned) meet scientific, regulatory, quality, cost, and commercialization requirements as pertain to their area of expertise.

* To provide statistical expertise to support the CSE and Statistics and Informatics (S&I) Section Directors to agree and establish standards and best practices to optimise the regulatory success and commercial value of AZ products, which will enhance the value and contribution of S&I.

* To promote, investigate, develop and implement novel statistical approaches in the expert area, for relevant statistical issues and/or regulatory guidance and/or value demonstration. To maintain broad awareness of statistical issues and the evolving regulatory environment relating to development of products within area. To examine external regulatory and scientific environment and identify any key areas, issues, trends, or emerging initiatives where direct involvement of AZ S&I would be beneficial and to provide or organize that direct involvement.

* To develop relationships with international opinion leaders and collaborative groups to enhance the value and contribution to function and statisticians in the external scientific/academic community.

* To provide consultation to relevant leadership teams and clinical team members on statistical issues, risk management, issue management and strategic direction.

* To provide expert consultation/perform statistical assessment/presentation of in-licensing/out-licensing proposals within the area of expertise

* Interact with Health Authorities and external consultants as appropriate. Support and defend design, analyses and their interpretation at Health Authority Meetings. Represent Statistics at FDA Advisory Committee meetings (and/or interact with clinical leaders and external experts for leading statistical support for publications of a very large, complex project)

* To provide expert consultation to the network of TASE/GPSs/Statisticians across area of expertise

* To act as mentor/coach for less experienced GPS/Statisticians within area of expertise

* To support S&I Section Directors, GPSs, and CSE in efforts aimed toward improving the overall quality and effectiveness of quantitative input to projects and in the achievement of S&I objectives

* To maintain good communications with fellow Statistical Experts and to be vigilant to statistical issues that have importance and relevance across areas, so that consistent technical approaches can be agreed across projects as appropriate and relevant learning is shared across the areas.

* To support the education and training of Statistics staff in relevant new statistical methodology through
* Effective and regular communication of relevant information from literature, meetings, conferences, regulatory guidelines etc.
* Organization of and participation in both local and regional seminars, workshops and meetings

Internal and External Contacts/Customers

* Internal -- iMED, GMD, Design and Interpretation Working Groups, Clinical Project Teams, Global Product Teams, Therapy Area Clinical Vice-Presidents, Chief Medical Officer, Chief Statistical Expert, Regulatory Affairs, Global Marketing
* External -- expert groups, Regulatory Authorities, professional/industry societies, expert advisors, and external partners

Reporting Relationships: No direct reports; Reports to Group Manager, Statistics (either locally or globally)

Requirements: 
Minimum Requirements --Education and Experience:

* Essential --MS/MSc in Statistics or Medical Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications or relevant areas of statistical applications.

Desirable --PhD in Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications

GPS

* Extensive experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues, from different phases of development
* Experience of effective use of modelling and simulation to improve clinical programme design and decision making
* Experience of quantification of benefit, risk, value and uncertainty
* Experience of major regulatory interactions and/or regulatory submissions
* For large products or products involving many indications, extensive experience of regulatory submissions in more than one continent. (eg Europe, US, Japan) and /or previous attendance at meetings with regulatory authorities

Statistical Expert

* Extensive expert area knowledge
* Extensive experience in area of expertise in the context of drug development within and beyond clinical studies
* Experience of effective use of modelling and simulation to improve clinical programme design and decision making
* High level of statistical expertise
* Extensive experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques, with different types of data and issues, from different phases of development
* Experience of quantification of benefit, risk, value and uncertainty
* Well respected and highly credible within the statistical arena

Desirable

GPS

* Product and/or TA or disease area knowledge
* Experience of commercial support (e.g. publication teams, HTA, PRO utilisation, outcome studies),
* For large products, strategic input to world-wide drug development and commercial support
* Other Product support such as in-licensing review, promotional complaints or issue management

Statistical expert

* Experience of major regulatory interactions and/or regulatory submissions
* Experience of commercial support (e.g. publication teams, HTA, PRO utilisation, outcome studies),
* Other Product support such as in-licensing review, promotional complaints or issue management

Leadership Capabilities:

* Leadership (Target Level 3 or higher of all Leadership Capabilities)
* Broad statistical knowledge (technical skills)
* Communication skills
* Strategic thinking and influencing
* Innovativeness
* Judgement/integrity
* Proven Project Management skills
* Negotiation Skills
* Cross Cultural Awareness
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