_Experienced Biostatistician – Regulatory Submissions (Poland)
_What will you do?
Responsibilities:
- Designs experimental protocols to collect relevant data to answer a particular research question, including methodology definition, sampling, sample size calculation and potential biases mitigation.
- Contribute to Data management plan and activities.
- Applies statistical techniques to analyze collected data and answer research questions. Creates statistical models to predict future outcomes, study relationships between variables and optimize processes.
- Interprets statistical analyzes results and communicates them to stakeholders in a clear and understandable manner to non-statistical expert for decision making.
- Contributes to collect user needs in terms of analysis or tools and identify opportunities for improvement.
_Who are we looking for?
Requirements:
- 5+ years of experience as a Biostatistician, with expertise in sampling strategies, hypothesis testing, and statistical modeling.
- Proficiency in programming languages such as R or SAS.
- Solid understanding of regulatory requirements, including familiarity with any of: CLSI, GMP, ISO, IVDR, and/or FDA
- Strong communication skills, with the ability to present complex statistical concepts to diverse stakeholders effectively.
Nice to have:
- Knowledge of IVD products or similar regulated product environments is highly desirable.
_Why is it worth it?
What can we offer:
- Work on impactful projects that shape healthcare and improve lives.
- Collaborate with a dedicated, professional team in a dynamic environment.
- Competitive salary and B2B contract.
By submitting my application, I declare that I agree that for the purpose of recruitment, in accordance with art. 6, clause 1, point a) of the General Regulation of the Protection of Personal Data created on April 27th 2016, my personal details will be processed by Transition Technologies PSC Sp. z o. o. with its registered office in Łódź (90-361), Piotrkowska street no 276, and by other entities from the Transition Technologies Group.
INFORMATION CLAUSE 1. We hereby inform that: 1) The administrator of your personal data is Transition Technologies PSC Sp. z o. o. with its registered office in Łódź (90-361) at Piotrkowska 276 street and other entities from the Transition Technologies Group 2) The person at Transition Technologies PSC Sp. z o. o. who provides information on personal data protection can be contacted via the following email address: hr_ttpsc@tt.com.pl 3) The processing of personal data in the scope provided in the application takes place in order to conduct and resolve the recruitment process, while the legal basis for their processing is art. 6, clause 1, point a) of the General Regulation on the Protection of Personal Data of April 27, 2016. 4) Your personal data may be transferred to other entities within the Transition Technologies group and partners of the Transition Technologies group with whom Transition Technologies cooperates in the recruitment process. 5) Your personal data will be stored for a period of 24 months from the moment of submitting the application. 6) You have the following rights related to the processing of personal data by the administrator: a) access b) rectification c) removal d) processing restrictions e) object to the processing f) transferring data to another personal data administrator g) object to the processing of my data in the process of automated decision making, including profiling. 7) You have the right to withdraw your consent to the processing of personal data at any time, without affecting the lawfulness of the processing that was carried out on the basis of consent before its withdrawal. 8) You have the right to lodge a complaint with the supervisory authority competent for the protection of personal data, if you consider that the processing of your data violates the provisions of the general regulation on the protection of personal data of April 27, 2016. 9) Providing your personal data is voluntary, however, necessary to participate in the recruitment process. 10) Your personal data will not be processed in the process of automated decision making.