is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Biostatistics Science Director - Oncology in Gaithersburg, Maryland,
you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.Main Duties and Responsibilities
As the Biostatistics Science Director - Oncology, you will provide expert and independent statistical leadership in support of a compound(s)/product(s) within a Therapeutic Area (TA). This includes guidance on statistical methods, appropriate study design and interpretation of results; strategic input into clinical development planning; and management of Analysis and Reporting (A&R) deliverables. You will function as a Global Product Statistician (GPS) by providing comprehensive statistical leadership for a compound(s)/product(s) within a Therapeutic Area (TA). Support the TA Biostatistics Head with respect to development of TA specific analysis methodologies and evaluation/implementation of TA specific regulatory guidance. Support the TA Biostatistics Head with respect to development of TA specific data and reporting standards. Lead the statistical thinking for all aspects of the development process including definition of the target product profile/claim, formulation of go/no-go/futility criteria, evaluation of benefit/risk profile, and development of associated regulatory strategy. Demonstrate a high degree of knowledge regarding their product(s) and TA including knowledge of the underlying disease(s) and potential mechanism(s) of action, current and past data from other drugs for the disease(s), scientific literature reporting mechanistic or clinical trial results and issues related to submission history of related products. Collaborate effectively with Clinical Research colleagues by driving statistical thinking, proper data interpretation and disciplined exploratory data analysis. Influence the broader organization with respect to innovation in clinical study design. Responsible for statistical sections of Protocol Concept Sheet (PCS), study protocols, Clinical Development Plans (CDPs), and integrated Product Development Plans (iPDPs). Lead development of components of regulatory submissions (eg, FDA briefing documents, response to FDA requests) and represent MedImmune/AZ Statistics to Health Authorities (eg, Pre-IND and EOP2 meetings). Define and lead the analysis of relevant internal and external information to inform design decisions. Responsible for statistical aspects of internal governance reviews. Authoring or overseeing authorship of Statistical Analysis Plans (SAPs). Authoring or overseeing authorship of Statistical Programming Plans (SPPs). Responsible for statistical content and data interpretation for Clinical Study Reports (CSRs) and publications or presentations. Manage A&R work on the product including deliverables provided by internal resources and outsourcing partners/providers. Effectively negotiate timelines or competing company priorities among a variety of stakeholders. Provide statistical guidance/oversight to Science Associate Directors or study-level statisticians. May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities. Ensure that internal standard procedures and working practice are followed.Essential Requirements
- MS or PhD in statistics or other related field with high statistical content
- Minimum 10 years of industry experience in clinical study environment including lead statistician role at compound level.
Next Steps - Apply today!
- Comprehensive knowledge of statistical methods and applications in study design and analysis.
- Ability to innovate creatively in a clinical study design setting.
- Ability to communicate with clarity and influence.
- Ability to challenge (in good faith) the broader clinical organization to drive organizational thinking and change.
- Ability to defend statistical methods or development strategy under senior level cross functional peer review.
- Ability to make tough decisions to drive the right business outcome.
- Knowledge of ICH/EMEA/FDA guidelines.
- Demonstrated ability to serve effectively as a delivery team leader.
- Demonstrated ability to manage and mentor project statisticians.
- Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.
- Experience in regulatory interactions and submissions.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.