Principal/Sr. Principal Statistician, Oncology
Location:
Gaithersburg , Maryland
Posted:
December 12, 2017
Reference:
R-012847
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. Principal Statistician, Oncology 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 (Senior Principal Statistician)
Senior Principal Statisticians 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).  Senior Principal Statisticians may be a newly appointed GPS who is developing into the full role or may lead a strategic capability or business area improvement. Senior Principal Statisticians are 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.
Additional responsibilities will include the following:
  • 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)
  • May provide highly experienced expert statistical leadership to the development of the capability area and to PDTs, promoting good statistical practice
  • May represent the company's position in their contacts with external experts
  • May also participate in providing statistical support/strategy for post-marketing/Medical Scientific Affairs activities
Essential Requirements (Principal Statistician)
  • MS or PhD in statistics or other related field with high statistical content              
  • Minimum 2 years of industry experience in clinical study environment as an independent lead study statistician, oncology experience is preferred.
Essential Requirements (Senior Principal Statistician)
  • MS or PhD in statistics or other related field with high statistical content                
  • Minimum 4 years of industry experience in clinical study environment as a lead study statistician, oncology experience in preferred.
  • Experience as a lead statistician at compound level (preferred)
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.

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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