Job opening for biostatisticians and Clinical Data Managers
4Pharma is expanding and we are looking for new talents to join us!
As a Biostatistician, you are responsible to provide statistical expertise in the design, planning, evaluation and documentation of clinical studies in all phases as well as in regulatory submissions. This will also include work of more exploratory nature, e.g. modelling and simulation aimed to facilitate decision-making. You are also expected to build and maintain customer relationships
Your tasks include clinical study design discussions, clinical protocols and Statistical Analysis Plan (SAP) development, preparing data standard and reporting specifications (ADAM and TFLs), conduct statistical programming (using SAS and R), performing statistical analyses, documentation of the results as well as discussing interpretation with customers. You will also be involved in internal process development and business development activities.
The Biostatistician work in close collaboration with 4Pharma’s statistical programmers, clinical data managers and medical writers as well as the clinical/medical teams at our customers.
You will be part of our experienced Biostatistics team and will work closely with both local and global customers. Your office location can be either in Lund (Sweden), Turku or Helsinki (Finland).
You have a MSc or an equivalent degree in statistics, mathematics or similar subject with a strong focus on statistics. Previous experience in pharmaceutical or CRO sectors is highly appreciated.
You have solid experience of programming (SAS and/or R) and a good understanding of clinical databases and industry data standards (CDISC) as well as reporting requirements.
Excellent skills in both written and spoken English is required. As a person, you are thorough, happy to take on responsibilities, proactive, flexible and enjoy working in a team. You are focused on quality and always have customer perspective on the top of your mind.
Clinical Data Manager
As a Clinical Data Manager you will have the overall responsibility of data management in clinical studies. You are responsible to review of the work of the database programmer, data management associate and data entry operator. You are also expected to build and maintain customer relationships.
Your tasks include coordination of data management activities in clinical studies. Creation and maintenance of databases in EDC systems and SAS by applying data standards (e.g. CDISC). Guide the database programmers, data management associates and data entry operators in daily data management activities. Conduct system training. Internal process development and business development tasks.
Daily work will include operative clinical data management, building eCRF, creating SDTM-datasets, data standards conformance checks, annotation of CRFs, technical solutions for data transfers etc.
You will be part of our experienced Data Management team and will work closely with both local and global customers. Your office location will be in Lund, Turku or Helsinki based on your preference.
You have a BSc or an equivalent degree in relevant statistics, computer science, programming or natural science discipline. Previous experience in pharmaceutical or CRO sectors is highly appreciated.
For a senior position you must have solid experience of clinical databases and a good understanding of SAS programming and industry data standards (CDISC). Experience with EDC (Electronic Data Capture) system is required.
Excellent skills in both written and spoken English are needed. As a person, you are thorough, happy to take on responsibilities, proactive, flexible and enjoy working in a team. You are focused on quality and always have customer perspective on the top of your mind.
What we offer
We offer you an exciting and challenging journey in a modern, flexible and growing company with a friendly working environment. Continuous training for further development is an essential part of our company culture.
We look forward to hearing from you!
Please send your CV and cover letter to email@example.com by March 7, 2020. We will review candidates as they come in.