Biostatistician M&E

WORKING AT MÖLNLYCKE
Are you looking for a great career and want to make your mark?
Please keep on reading but don’t just take our word for it. We’ve interviewed colleagues around the world about their jobs, the Mölnlycke unique culture and Mölnlycke people and it is simply A great company to work for!
Could you help improve healthcare outcomes around the world?
If the answer is yes, you think just like us and should apply for this exciting opportunity that we have below.
We are currently recruiting for a Biostatistician to join our Medical & Economic Affairs department. This role operates globally and can be performed from our Mölnlycke offices around Europe, therefore we are happy to receive applications from both Sweden and Europe. The purpose of this position is to be accountable for the statistical activities within the M&E department, including internal as well as external activities. The role should establish clear communications and alignments with relevant internal and external stakeholders in regards to how available and future clinical data can be utilized to meet business & regulatory needs from a statistical perspective. In this role, proficient English written and spoken is necessary.


KEY ACCOUNTABILITIES
Being part of cross functional teams, to lead the biostatistician parts in projects within and outside M&E.
Contribute to Mölnlyckes’ strong drive to be on the cutting edge of data science in line with the company’s objectives
Effectively communicate with clinical operations, medical affairs, health economic, marketing and IT teams
Accountable for providing the right input around statistics for clinical activities e.g study design and protocol development, statistical analysis plan (SAP), statistical analysis report (SAR), sample size analysis, etc
Proactively, together with relevant stakeholders, identify new way of analysing and using clinical data, to meet business and regulatory needs
Responsible to provide input on Investigator Initiated Studies (IIS) as requested by the IIS Committee, i.e. statistical considerations.
Accountable for dedicate the right statistical resource for a clinical activity, internal resource or external.
Responsible to order relevant services within statistic and be the point-of-contact
Educate and share knowledge on statistical analysis



KEY DECISIONS
Statistical decisions as well as considerations related to aspects of clinical activities such as clinical Investigation Plan, registry study, survey, etc.
Place the right order at external statistical providers, to secure the right statistical competence available in clinical projects


CAPABILITIES; QUALIFICATIONS AND EXPERIENCE
Relevant medical/scientific/computer education on MSc level or equivalent
5-7 years biostatistics (and data management) within clinical research area (medical device, pharmaceutical or from a CRO)
Solid training in clinical research methodology and in biostatistics
Good networking and organizational skills as well as entrepreneurial sense of ownership and execution
Knowledge in national and international requirements and regulations within the area of clinical studies for medical devices.
Experience with statistical data analysis software
Experience of working with clinical data, databases, project management and working as part of a multidisciplinary team
Fluent in English (written and spoken)


Please apply at your earliest convenience as the applicantions will be reviewed continously.


About Mölnlycke
Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day.
We specialize in:
• Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®
• Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients
• Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves
Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.