Statistical Science Director V&I

Are you ready to lead and innovate in the world ofclinical statistics

As a Statistical Science Director at AstraZenecayoullleverageyour extensive experience in the pharmaceutical industry to independently guide statistical strategies and technical activities. Whetheritsdesigning delivering or interpreting data for high-level governance committees or regulatory submissions yourexpertisewill be pivotal.Youllalsohave the opportunity tobe recognized externally asa methodologyexpert leading technical analyses and mentoring less experienced staff. Join us and collaborate across functions to make a real impact!

Whatyoulldo:

In this role you will be responsible in leading 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.

You will provide 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.

You will apply expert skills to investigate apply novel statistical approaches forrelevant statisticalissuesand/or regulatoryguidanceand/or value demonstration. You will mentor/coach and support the education and training ofstatistics staff in the technical arena.

Theaccountabilitiesfor supporting projects directly include:

• Lead the statistical design and strategy to product development plans preclinical studies regulatory strategy health technology assessment and/or commercial activities asappropriate forthe stage of the product.

• Lead the statistical content and ensure quality for study designs documents delivery interpretation and submission.

• Quantify the benefit risk value and uncertainty of the emerging product profile and communicate these effectively within the team.

• Provide global leadership to others and direct project work delivered by internal and external staff.

• Partner with CROs to ensure delivery to quality and time.

• Represent AstraZenecaexternallywhich may include health authorities advisory boards conferences workshops and/or payer interactions.

• Maintain knowledge of statisticalmethodologyin relevant areas and promote investigate and implement novel statistical approaches.

• Represent statistical strategy and decision-making at internal governance including review boards therapy area leadership teams and ESPC/LSPC.

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

The accountabilities for supporting statistical methodological advances are (technical focus):

• In-depth knowledge of technical/regulatory requirements with experience in pharma/healthcare.

• Stay up-to-date and implement novel statistical approaches.

• Experiencewith andbroad awareness of regulatory interactions and/or submissions.

• Excellent communication skills/build strong relationships.

• Nationally recognized externally. Invited to attend or speak at seminars and external meetings. Well-rounded statistician with publications on a range of topic areas. Publications resulting from external collaborations.

• Expert Leadership role able to lead/direct work across a team.

Whatwerelooking for:

This role requires an individual with outstanding technical skillsleadership and the ability to guide and support multiple studies while fostering team development and project success.

Essential Skills/Experience:

• MSc/PhD in Statistics Mathematics (with asubstantialstatisticalcomponent) or a recognized equivalent to a stats MSc.

• Proventrack recordof independent leadership.

• 5 years of experience in clinical trialsis criticalfor this role.

• Recognized for exemplary technical skills and expert leadership role or national recognition as a statistical technical expert.

• Demonstrated ability to provide cross-study support overseeing aligning and providing technical support formultiplestudies.

Desirable Skills/Experience:

• Experience in Vaccines & Immunotherapy is a strong asset but open to other therapeutic areas (TA).

• Implemented simulation programming for sample size calculations or interim analyses.

• Experience with business development opportunities such asin-licensing would be beneficial.

• Proficiencyin programming languages such as SAS R and Python.

• Strong project management skills.

• Excellent communication skills especially in relation to project managementensuringeffective cross-functional collaboration and stakeholder engagement.