Statistical Programmers, Late-Stage CVRM Biometrics, AstraZeneca Gothenburg

Are you interested in becoming part of the group of statistical programming at AstraZeneca R&D Gothenburg? Late-stage Cardiovascular, renal and Metabolism Biometrics is now looking for Statistical Programmers for on-site contract assignments with start as soon as possible.

To be considered for this exciting consultant opportunity at AstraZeneca in Mölndal, please complete the application at your earliest convenience. If you know someone who would be a great fit, please share this posting with them.


Om tjänsten
You would join a team of statisticians and statistical programmers to provide programming expertise to the design, conduct, reporting, interpretation, documentation and regulatory submissions of our clinical development programs. Depending on your experience, you may contribute to more strategic planning, quantitative decision making, act as expert in our contact with external providers and collaborators, manage projects and be a part of the function's adaptation and development of programming tools, standards and praxis.

Dina arbetsuppgifter i huvudsak
• Lead and/or contribute to the planning, preparation and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Monitor and interpret the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
o Submission delivery strategy of all dossiers and all application types per market and/or region.
o Review of documents (e.g. response documents, study protocols, PSRs etc.).
o Analysis of regulatory procedures and special designations used during development, authorizations and extensions of a medicinal product.
• Support operational and compliance activities for assigned regulatory tasks.
• Provide coaching, mentoring and knowledge sharing within the regulatory skill group.
• Contribute to process improvement.

Vem är du?
Required Background
• Minimum educational level is a BSc degree in a relevant subject such as statistics, biostatistics, mathematics, computer science, life science or engineering.
• Good collaboration, communication and influencing skills
• Good written and spoken English
• Experience in using programming to structure and analyze data, in at least one tool, such as SAS, R, SQL and Python

Other relevant qualifications
• Higher academic degree
• Experience from clinical data standards, drug development or other related fields
• Expertise in multiple programming software such as SAS, R, SQL and Python
• Experience from drug development or other related fields
• Project management experience

Personal Qualities
Candidates should possess good social skills, be strong team player and be able to work effectively in a global organization where teams often are geographically dispersed. You should be able to work independently, take own initiatives and have a positive, goal oriented and problem-solving attitude. It is essential to have good organizational and communication skills and you should be able to analyze and summarize your results and be comfortable in presenting them. Successful candidates will have the ability to communicate subject matter expertise to other experts, as well as an interest in the application of programming in pharmaceutical development.

Om verksamheten
AstraZeneca is a global biopharmaceutical company committed to the development of the next generation innovative medicines. From scientists to sales, we’re on a mission to turn science into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.


For more information about the position please contact Jenny Lundkvist.
Welcome with your application no later than May 24th, 2020.

If you are interested, apply now!