Location:Gaithersburg, United StatesJob reference:
Oct. 12, 2016
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 Senior Principal Statistician / Science Associate Director 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
Please note this this position can be filled at either the Senior Principal Statistician level or the Science Associate Director level.
Senior Principal Statistician- You will provide highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and clinical development programs in support of the Global Product Statistician (GPS). You may be a newly appointed GPS who is developing into the full role or may lead a strategic capability or business area improvement. You will be expected to complete these tasks with minimal supervision, appropriately and pro-actively consulting with key stakeholders (eg, GPS) and line management where needed to ensure a successful outcome to agreed time, cost and quality. Provide statistical leadership in support of the Global Product Statistician (GPS), be a newly appointed GPS, or lead strategic capability or business area improvements with minimal supervision. Serve as primary author for statistical sections of protocol concept sheets (PCS), protocols, clinical development plans (CDP), and integrated product development plans (iPDP). 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. Define and lead analysis of relevant internal and external information to inform design decisions. Provide statistical support and leadership to clinical trial teams (CTT), clinical sub-teams (CST) and product development teams (PDT) on the development of Target Product Profile and Target Product Claims (TPP/TPC), Benefit, Risk, Value and Uncertainty (BRV(U)), clinical development plans (CDP), and regulatory strategy. Lead development of components of regulatory submissions (eg, briefing documents, response to FDA requests, BLA/NDA, and sBLA/sNDA) and may represent MedImmune/AZ Statistics to Health Authorities (eg, Pre-IND and End of Phase II meetings). You may provide highly experienced expert statistical leadership to the development of the capability area and to PDTs, promoting good statistical practice. You may represent the company's position in their contacts with external experts, and you may also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities
Science Associate Director- You will provide 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. Function as a Global Product Statistician (GPS) by providing comprehensive statistical leadership for a compound(s)/product(s) within a Therapeutic Area (TA). 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 knowledge regarding disease(s) under study, potential mechanism(s) of action and approval pathways/histories of other current/past drugs. Collaborate effectively with Clinical Research colleagues by driving statistical thinking, proper data interpretation and disciplined exploratory data analysis. You will be 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. You will be 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). You will be responsible for statistical content and data interpretation for Clinical Study Reports (CSRs) and publications or presentations. Managing 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 study-level statisticians. You 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.
* MS or PhD in statistics or other related field with high statistical content.
Senior Principal StatisticianLevel:
* Four or more years of industry experience in clinical study environment as a lead study statistician.
Science Associate DirectorLevel:
* Six or more years of industry experience in clinical study environment including lead statistician role at compound level.
Senior Principal Statistician Level:
* Comprehensive knowledge of and experience with statistical methods and applications in study design and analysis
* Ability to effectively oversee work of outsourcing partner
* Ability to effectively collaborate, communicate, and influence throughout multiple levels of the organization
* Experience in development of clinical development plans, protocols, statistical analysis plans, and clinical study reports
* Experience as an independent lead statistician with responsibility for multiple studies or projects
* Experience in regulatory interactions and submissions
* Experience as a lead statistician at compound level.
Science Associate Director Level:
* 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.
* Knowledge of ICH/EMEA/FDA guidelines.
* Demonstrated ability to serve effectively as a delivery team leader.
* 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.
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