If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune 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 Principal/Sr. Statistician in Gaithersburg, MD, 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 (Principal Statistician)
Principal Statisticians provide statistical expertise to the design and interpretation of clinical studies and clinical development programs under the guidance of more senior staff. They provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work. They engage in analyses to exploit information to improve design and decision-making. They support the Global Product Statistician (GPS) in providing statistical support to the clinical trial team (CTT), the clinical sub-team (CST) and Product Development Team (PDT). They take on responsibility for components of regulatory submissions including specification and construction of overview documents and responses to regulatory questions. Principal Statisticians may also contribute to/ or lead process improvement or a capability area within the Department.
Additional responsibilities will include the following:
- Provide statistical expertise under the guidance of more senior staff
- Serve as primary author for statistical sections of protocols
- Perform statistical analyses and create statistical text for clinical publications and other communications
- Provide direction and statistical oversight to outsourcing partners/providers regarding requirements and standards for study-level work, holding partners/providers accountable for the quality of their deliverables
- Engage in analyses to exploit information to improve design and decision-making
- Support the GPS on the development of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plan (CDP), and regulatory strategy
- Take on responsibility for components of regulatory submissions
- May participate in interactions with Health Authorities.
- May also contribute to/or lead the development of a process improvement and/or capability area within the Department
- May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities
Main Duties and Responsibilities (Sr. Statistician)
Senior statisticians work with senior staff in providing statistical support to clinical trial design, data analysis and results interpretation for clinical studies at different phase of development. They engage in using modelling and simulations to exploit information to inform design and decision-making. They work with programming team (internal or external) to implementing statistical analysis plan. Senior statisticians work with the Global Product Statistician (GPS) as a statisticians' team to provide statistical input to compound development, and actively participate at the Clinical Trial team (CTT) and the Clinical Development Sub-team (CST).
Additional responsibilities will include the following:
- Being an integral part of a statisticians team supporting compound development across several therapeutic areas
- Supporting protocol design with modelling/simulations, and/or historical data review/synthesis.
- Authoring Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP) under the supervision of senior staff
- Implementing the SAP and SAP by working with programming team closely
- Supporting Clinical Study Report writing
- Supporting scientific data dissemination
- Support the GPS on the development of Target Product Profile, clinical development plan (CDP), and regulatory strategy
- Supporting documents for regulatory interaction
Essential Requirements (Principal Statistician)
Education: MS or PhD in statistics or other related field with high statistical content
Experience: Minimum 2 years of industry experience in clinical study environment as an independent lead study statistician
- Comprehensive knowledge of and experience with statistical methods and applications in clinical study design and analysis
- Effective oral and written communication and interpersonal skills
- Ability to effectively oversee work of outsourcing partner
- Experience in development of protocols, statistical analysis plans, and clinical study reports
Essential Requirements (Sr. Statistician)
Education: MS or PhD in statistics or other related field with high statistical content.
PhD 0-2 years and MS 1.5-3 years of industry experience in clinical study environment as a study statistician
Solid knowledge of statistical methods and applications in clinical trial design and analysis Effective oral and written communication and interpersonal skills Proficiency in SAS and R languages Knowledge of Bayesian statistics from theory to computation is a plus.
Next Steps - Apply today!
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.