Senior Statistical Science Directors combine their managerial experience, drug development experience, technical expertise and leadership to contribute to drug programmes as well as development of staff within Statistics & Programming. They provide highly experienced strategic, statistical support and leadership to product teams, disease areas, or specialised areas (e.g. patient safety, clinical pharmacology alliance, personalised healthcare), and the Statistics & Programming Department.
They are externally recognized experts either within a Therapeutic Area (TA) or technical area and have an external focus through attending/presenting at conferences, participation in external initiatives and/or producing publications.
The main roles undertaken by the Senior Statistical Science Directors are a combination of Group Manager and Global Product Statistician (GPS) or Statistical Expert. The Senior Statistical Science Directors provide leadership in a drug program through the Global Product Statistician role while also managing direct reports through the Group Manager role. Alternatively, the Senior Statistical Science Directors may provide specific technical expertise and leadership as a Statistical Expert to Statistics & Programming while also managing direct reports. The Senior Statistical Science Directors may act as delegates for members of the Biometrics & Information Sciences (B&I) Leadership Team in addition to their group manager responsibilities.
The focus of the key roles differs by area and below is specific information on the accountabilities for each area of specialisation.
* To lead, manage and develop a group of statisticians:
o To share and interpret the AstraZeneca (AZ), Global Medicines Development (GMD), BILT and Statistics and Programming vision and objectives to their direct reports
o To proactively address the recruitment pipeline and effectively recruit staff when necessary
o Manage the performance of direct reports through the production, monitoring and annual review of individual objectives and development plans
o To ensure statistical standards, regulatory compliance and SHE standards are met by direct reports
o To manage talent, including identifying appropriate opportunities for staff, developing an effective succession plan and discussing career options with their direct reports
* To provide leadership and direction to improvement projects/activities/initiatives and drive the implementation of best practice across the group.
* To ensure drug projects are successfully delivered:
o To provide statistical and scientific leadership and expertise to clinical projects; coach and advise statisticians in project teams
o To work effectively with GPS and Clinical Project Teams(CPT) to understand the current and future resource demands ensuring projects are effectively and proactively resourced with the right skill levels
* To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation of AZ products.
* 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
o Through partnership with relevant internal and external experts, developing design options and providing high quality decision support to enable the business to make informed decisions
o Quantifying the benefit, risk, value and uncertainty of the emerging product profile throughout the lifecycle of the drug development process.
o Setting the standards (and enforcing compliance) for statistical work within the product;
o Holding CRO/Partners accountable for the high quality standards of their clinical and statistical deliverables;
* Represents AZ and Statistics to Health Authorities worldwide;
* To provide an expert statistical review and consultancy globally across all the drug projects within their area of expertise and provide strategic and expertise to relevant management and leadership teams.
* 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 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.
* To develop relationships with international opinion leaders and collaborative groups in the external scientific/academic community and interact with Health Authorities and external consultants as appropriate; interact with clinical leaders and external experts for leading statistical support for publications in area of expertise.
* To act as mentor/coach within area of expertise and support the education and training of Statistics staff in the technical arena.
* Leadership (Target Level 3 or higher of all Leadership Capabilities)
* Acts Decisively
* Thinks Strategically
* Develops Others
* Drives Performance
* Passion for Customers
Internal and External Contacts/Customers
* Internal -- iMED, GMD, Design and Interpretation Working Groups, Clinical Project Teams, Global Product Teams, Global Medicines Development VPs, Chief Medical Officer, Regulatory Affairs, Global Marketing, Governance Bodies
* External -- expert groups, Regulatory Authorities, professional/industry societies, expert advisors, and external partners
Reporting Relationships: Manages direct reports; Reports to Section Director- Statistics & Programming (either locally or globally)
Minimum Requirements --Education and Experience:
* MSc (Masters) or PhD in statistics (or closely related discipline) with at least 10 years experience in the pharmaceutical or a related industry/field
* Managerial experience
* Comprehensive knowledge of clinical drug development process including experience providing input to drug development and commercialization strategies
* Experience with regulatory submissions and interacting with regulatory authorities
* Extensive experience in clinical data analysis using a variety of designs and statistical techniques, exposure to different data types and issues, experience with multiple phases of clinical development, and/or experience with drug development in several different therapeutic areas
* Willingness to travel as necessary
* Excellent communication skills
* Extensive expert area knowledge (either TA or technical)
* Well respected and highly credible within the statistical arena and recognized expert across the industry
* 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
AstraZeneca - 2 years ago
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