Biostatistician – Stockholm - Avslutad

As a biostatistician you are a member of the clinical team and have responsibility for the statistical aspects of project and study activities, e.g. the design, preparation, review and approval of statistical analysis plans, clinical study protocols, reports and publications.

The Statistics and Data Management group is responsible for providing biostatistics, programming, data management and medical writing support through all phases of clinical development, for post-marketing and life-cycle management.

Main assignments

  • Contribute to the establishment of Target Product Profile (TPP) and Target Labels
  • Provide statistical expertise in regulatory submissions and regulatory defense activities. Participate in the preparation and review of integrated reports and regulatory response documents
  • Provide statistical support in post-marketing activities and safety updates
  • Contribute to the writing of publications and abstracts
  • Establish and maintain company standards for good statistical practices and ensure standards are being followed internally and externally
  • Provide leadership, project coordination and prioritization of the statistical deliverables
  • Collaborate with internal statisticians to drive best practices and implement new initiatives
  • Stay informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings

Who you are

You have a university degree in Statistics combined with at least five years of biopharmaceutical experience in the design and analysis of clinical studies with focus on later phases and experience in SAS programming. You will also need to have experience working with CROs in the area of out-sourced clinical studies. Furthermore, a sound understanding of regulatory guidelines in a pharmaceutical research setting as well as of theoretical and applied statistics are needed.

More information and application

You are welcome to call Mr Knut Natt och Dag on 0722 166 800 or Mr Rolf Mayer on 0708 87 60 05 if you have any questions concerning this position. Send your application with your CV and a short personal letter to knut.nattochdag@aktivia.se as soon as possible due to our on-going work with this recruitment. Write “Biostatistician” in the subject field.

You will be employed by Aktivia Science Work AB and will work as a consultant in our client company. The employment is full time during the entire 2013. There are possibilities that the project will be prolonged.

Aktivia Science Work AB is a consultant company within Life Science specialized in positions within the pharmaceutical industry. We have offices in Stockholm and in Lund and are part of Karolinska Institute Science Park in Stockholm and the Life Science centre in Lund. We are members in SwedenBIO and Medicon Valley Alliance. You can read more about us on our website, www.aktivia.se.

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