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Project Statistical Programmer

 
Requistion ID:  1397
Location: 

Copenhagen, N/A, DK

Date: 
 

Project Statistical Programmer

Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with brain diseases. We operate within the therapeutic space of: Depression, Parkinson’s, Alzheimer’s, Schizophrenia and Migraine within which we have 10+ clinical projects spread across the development phases. We are currently in the process of expanding and rebuilding our pipeline and need the help of an experienced statistical programmer.

 

We are looking for an experienced statistical programmer who can step into the role as Project Programmer within one of our clinical projects. You will be employed in the Statistical Programming section and thus be part of a fantastic team of 12 skilled programmers. The section is part of the Biostatistics & Programming Department within the Biometric Division.

 

Your job

As an Project Statistical Programmer, you will be overall responsible for the statistical programming tasks within one of our clinical projects. Your tasks will include, but not be limited to:

  • Be overall responsible for programming tasks within a project
  • Coordinate the programming tasks in collaboration with the Project Biostatistician
  • Have hands-on responsibilities with integration of data, creation of summaries, project standards development in accordance with CDISC standards, and alignment across studies
  • Provide programming input to submission plans, authority interactions and individual clinical studies
  • Ensure project programming input to agreements and work orders with vendors, and perform sponsor oversight of outsourced programming activities, including verifying CDISC conformance
  • Act as Study Programmer on one or more studies including programming/QC of ADaM datasets and tables, figures and listings
  • Plan for and support the development of tables, figures and listings, for e.g.: regulatory submission documents, IB, DSUR, PSUR and the answering of biometric related questions raised by regulatory authorities
  • Plan and coordinate data transfers to and from business partners e.g. for DMC meetings, Interim Analyses, sharing of data with partners

 

We offer

In this setting, we offer an attractive and challenging job in a dynamic atmosphere with great opportunities for personal and scientific development and with a focus on a good work-life balance.

 

Your qualifications

Our preferred candidate:

  • has a master’s degree within natural sciences or similar
  • has profound experience as statistical programmer within drug development
  • is a skilled SAS programmer
  • Keeps up with development within relevant CDISC standards and electronic submission requirements and guidelines
  • Is a strong communicator
  • Enjoys interaction with colleagues and collaborators from different functional areas
  • is fluent in oral and written English

 

Further information

For further information, please contact Manager of Statistical Programming, Jenny Færch on jfae@lundbeck.com. We also recommend that you visit http://www.lundbeck.com/

 

Your application

To apply for the job, please go to http://www.lundbeck.com/global/career where you will find this position in the list of open positions. Applications must be received no later than 1st of November 2020.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
 
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
 
Read more at www.lundbeck.com/global/about-us/progress-in-mind
 
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.