Statistical Science Director

Location: Barcelona Spain (3 days working from the office and 2 days working from home)

Join us on this exciting journey to pioneer the future of healthcare. Our inclusive culture champions diversity and collaboration and we are always committed to lifelong learning growth and development. As part of our team youll contribute to groundbreaking advancements that will shape a healthier future for people everywhere. Be a catalyst for change at AstraZeneca where your work will have a real impact on improving peoples lives.

Recognizing the importance of individualized flexibility our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging facetoface in our offices 3 days a week. Our head office is purposely designed with collaboration in mind providing space where teams can come together to strategize brainstorm and connect on key projects.

About the Opportunity:

Are you ready to lead and innovate in the world of clinical statistics As a Statistical Science Director at AstraZeneca youll leverage your extensive experience in the pharmaceutical industry to independently guide statistical strategies and technical activities. Whether its designing delivering or interpreting data for highlevel governance committees or regulatory submissions your expertise will be pivotal. Youll also have the opportunity to be recognized externally as a methodology expert leading technical analyses and mentoring less experienced staff. Join us and collaborate across functions to make a real impact!

What youll do:

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 for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of statistics staff in the technical arena.

The accountabilities for 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 as appropriate for the 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 AstraZeneca externally which may include health authorities advisory boards conferences workshops and/or payer interactions.

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

• Represent statistical strategy and decisionmaking 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):

• Indepth knowledge of technical/regulatory requirements with experience in pharm/healthcare.

• Stay uptodate and implement novel statistical approaches.

• Experience with and broad 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. Wellrounded 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.

What were looking for:

This role requires an individual with outstanding technical skills leadership 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 a substantial statistical component) or a recognized equivalent to a stats MSc.

• Proven track record of independent leadership.

• Extensive experience in clinical trials critical for this role.

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

• Demonstrated ability to provide crossstudy support overseeing aligning and providing technical support for multiple studies.

Desirable Skills/Experience:

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

• Experience with business development opportunities such as inlicensing would be beneficial.

• Proficiency in programming languages such as SAS R and Python.

• Strong project management skills.

• Excellent communication skills especially in relation to project management ensuring effective crossfunctional collaboration and stakeholder engagement.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.