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Location:
Gaithersburg, Maryland, United States
Cambridge, England, United Kingdom
Job reference: R-025542
Posted date: Aug. 12, 2018
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My company shares my passion for helping to improve human health around the world.

"This is My MedImmune"

Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly‐owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities... that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in autoimmunity, infection, oncology, respiratory disease and inflammation, and cardiovascular/metabolic disease. Explore a MedImmune career as we strive to better more lives, more often, around the world.

Position Summary/Major Duties/Qualifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Please note this this position can be filled at either the Senior Statistician level or the Principal Statistician level.

Senior Statistician

Position Summary:

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).

Major Duties

  • 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 

Qualifications:

·        Education: MS or PhD in statistics or other related field with high statistical content        

·        Experience: PhD 0-2 years and MS 1.5-3 years of industry experience in clinical study environment as a study statistician

Special Skills/Abilities:

·        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.

Principal Statistician

Position Summary:

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 using modelling and simulations to exploit information to inform design and decision-making. They support the Global Product Statistician (GPS) in providing statistical input to the Clinical Trial Team (CTT), the Clinical Development Sub-team (CST) and Product Development Team (PDT). Principal Statisticians may also contribute to/ or lead process improvement or a capability area within the Department. 

Major Duties

  • Being an integral part of a statisticians team supporting  compound development across several therapeutic areas
  • Working with clinical teams for protocol development and serving as primary author for statistical sections of protocols under the guidance of more senior staff
  • Supporting protocol design with modelling/simulations, and/or historical data review/synthesis
  • Authoring Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP) under the guidance  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 
  • May also contribute to/or lead the development of a process improvement and/or capability area within the Department


Qualifications:

·        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 study statistician

Special Skills/Abilities:

·        Comprehensive knowledge of and experience with statistical methods and applications in clinical study design and analysis

·        Effective oral and written communication and interpersonal skills

·        Experience in development of protocols, statistical analysis plans, and clinical study reports

·        Ability to effectively oversee work of outsourcing partner

·        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.

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Senior Statistician/Principal Statistician
MedImmune

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