Hansa Biopharma is a fast-growing biopharmaceutical company, developing immunomodulatory treatments for enabling transplantations, rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy and cancer. The Company’s lead product candidate, imlifidase, has been granted conditional approval in the European Union for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Commercial launch in select European countries is expected in the fourth quarter of 2020. Hansa’s research and development program is also advancing the Company’s enzyme technology to develop the next generation of IgG-cleaving enzymes with potentially lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology. Hansa Biopharma is based in Lund, Sweden and has also operations in other European countries and in the U.S.
We are seeking an experienced and highly motivated Biostatistician based in Hansa Biopharmas´s HQ in Lund. In the role as Biostatistician you will be involved in all the statistical activities of our clinical studies, working closely with both the Clinical Research Manager (CRM) and the Biometrics Manager. You will be involved in several projects and studies simultaneously and report to the Director of Clinical Operations.
You will be part of the Clinical Operations department which is focused on conducting clinical trials in transplantation and auto-immune diseases. Currently we consist of 16 highly skilled and dedicated colleagues. Main tasks and responsibilities in the position are:
· Study design and sample size calculations
· Provide input to statistical sections of trial protocols
· Support and oversee our CROs delivering studies from the clinical study protocol to study reports
· Review deliverables from our CROs such as
– Statistical analysis plans
– Tables, listings and figures
– CRT packages
– Data management documents (CRF, DVP, DMR)
· Build up in-house routines for statistical activities
· Lead statistical contributions to regulatory submissions and approvals.
In order to succeed in this position, we believe that you have:
· MSc or an equivalent degree in relevant statistics, computer science or natural science discipline
· At least 5 years experience in working with clinical trials/designed experiments in pharmaceutical/CRO sectors as a biostatistician
· Good understanding of various study designs and statistical methodologies used in clinical trials
· Experience of statistical programming using SAS or R
· Fluency in written and oral English and Swedish languages skills an advantage
You as a person:
Our culture here at Hansa is really important, for the best possible organizational match, we hope you recognize yourself as you read our requirements:
We put great emphasis on you being well structured and thorough in your way of working. You enjoy communicating and collaborating with others and since you will be working with different projects in parallel, we also expect you to be flexible and open minded to changes in your day to day business.
The atmosphere is open-minded and together with your team colleagues you strive to make further contributions to Hansa Biopharma´s field of research!
What we offer:
· A position in a company that envisions a world where patients with rare immunologic diseases can lead long and healthy lives.
· Be part of an innovative R&D driven organization with an urge to make a difference for people and society.
· An opportunity to be part of building a fully integrated biopharmaceutical company with global outreach.
· A creative and positive atmosphere.
· Friendly, motivated and skilled colleagues that both laughs and works together.
Type of employment:
A full time permanent position, working on-site at our office in Lund. Starting date as soon as possible.
Please apply for the position by following the link:
Attach your CV and a cover letter in English, we are eager to learn more about you.
The last day for applications is October 18 but the process is ongoing and can therefore be shortened.
For questions regarding the position and process please contact the Biometrics manager Kjell Rasmusson at email@example.com.
We are looking forward receiving your application – you are needed and part of a bigger picture.
Department: Clinical Operations
Location: Scheelevägen 22
+46 46 16 56 70