Lediga jobb som Bioinformatiker i Mölndal

Job description
Senior Biostatistician - Ribocure Pharmaceuticals AB, Gothenburg

Are you a person who is passionate about contributing to drug development and has a background in biostatistics with pharma experiences? Then make sure not to miss this unique chance to come along on a journey where you can make a difference! 
 
Ribocure Pharmaceuticals AB in Gothenburg, focusing on oligonucleotide drug development, is looking for a senior biostatistician to join the team. They offer a vibrant collaborative, international environment where science and data are the main driving forces behind their ambition to develop game-changing medicines for patients. Ribocure Pharmaceuticals AB (Ribocure) is a newly formed international R&D center based in Gothenburg and is a subsidiary of Suzhou Ribo Life Science Co., Ltd. (Ribo). Ribocure is presently custom designing an amazing new floor in GoCo Clinic at GoCo Health Innovation City in Mölndal, where they will move in June 2023. 
 
Randstad Life Sciences is specialized in competencies within Life Science. As a consultant with us, you get a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures you get varying and developing assignments. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Please apply at www.randstad.se, no later than 2023-02-15. If you have questions, please contact [email protected].
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.




Responsibilities
Be part of the clinical team and responsible for the statistical aspects of the clinical study design
Accountable for writing statistical analysis plans 
Be responsible for choosing statistical analysis methods and randomization procedures
Program statistical analyzes in accordance with study protocols and statistical analysis plans, as well as perform statistical analysis of clinical study data
Contribute to the further development of statistics and programming-related processes and templates
Be part of the statistical network and in contact with key experts in the field to continuously improve our data science function
Duties may also include day to day tasks related to biostatistical questions derived from the clinical core lab unit. You need to be an agile and science-driven team player and will be a member of our international drug discovery team.








Qualifications

Essential for the role:


PhD in one of the following fields: biostatistics, statistics, applied mathematics, computational biology, or a closely related field relevant to the position
Experience of working in pharma or biotech companies
Previous experience in statistical design of clinical studies 
Good knowledge of database modeling and data management
Good knowledge of common statistical software programs (e.g. SAS, Stata, SPSS, R).
Very good ability to communicate in English, both verbally and in writing. 
Ability to, at an internationally competitive level, independently carry out and critically evaluate data analysis at an internationally high standard.
Demonstrated ability to work collaboratively in a matrix organization and in detail-oriented tasks in a team setting, with a commitment to service.




Desirables for the Role


Good knowledge in other data science aspects such as bioinformatics and mathematical modelling




About the company

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

Job description
Senior Biostatistician - Ribocure Pharmaceuticals AB, Gothenburg

Are you a person who is passionate about contributing to drug development and has a background in biostatistics? Then make sure not to miss this unique chance to come along on a journey where you can make a difference! 
 
Ribocure Pharmaceuticals AB in Gothenburg, focusing on oligonucleotide drug development, is looking for a senior biostatistician to join the team. They offer a vibrant collaborative, international environment where science and data are the main driving forces behind their ambition to develop game-changing medicines for patients. Ribocure Pharmaceuticals AB (Ribocure) is a newly formed international R&D center based in Gothenburg and is a subsidiary of Suzhou Ribo Life Science Co., Ltd. (Ribo). Ribocure is presently custom designing an amazing new floor in GoCo Clinic at GoCo Health Innovation City in Mölndal, where they will move in June 2023. 
 
Randstad Life Sciences is specialized in competencies within Life Science. As a consultant with us, you get a competitive salary, benefits, and collective agreements. Your consultant manager is always there for you and ensures you get varying and developing assignments. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Please apply at www.randstad.se, no later than 2022-12-12. If you have questions, please contact [email protected].
For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.




Responsibilities
Be part of the clinical team and responsible for the statistical aspects of the clinical study design
Accountable for writing statistical analysis plans 
Be responsible for choosing statistical analysis methods and randomization procedures
Program statistical analyzes in accordance with study protocols and statistical analysis plans, as well as perform statistical analysis of clinical study data
Contribute to the further development of statistics and programming-related processes and templates
Be part of the statistical network and in contact with key experts in the field to continuously improve our data science function
Duties may also include day to day tasks related to biostatistical questions derived from the clinical core lab unit. You need to be an agile and science-driven team player and will be a member of our international drug discovery team.




Qualifications

Essential for the role:


PhD in one of the following fields: biostatistics, statistics, applied mathematics, computational biology, or a closely related field relevant to the position
Previous experience in statistical design of clinical studies 
Good knowledge of database modeling and data management
Good knowledge of common statistical software programs (e.g. SAS, Stata, SPSS, R).
Very good ability to communicate in English, both verbally and in writing. 
Ability to, at an internationally competitive level, independently carry out and critically evaluate data analysis at an internationally high standard.
Demonstrated ability to work collaboratively in a matrix organization and in detail-oriented tasks in a team setting, with a commitment to service.




Desirables for the Role


Experience of working in pharma or biotech companies 
Good knowledge in other data science aspects such as bioinformatics and mathematical modelling




About the company

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus! Visa mindre

DMPK Department with Early Respiratory & Immunology

Hays Life Sciences is now looking to recruit a Preclinical DMPK lead (with focus on Pharmacology, data mining and programming) to join the DMPK Department with Early Respiratory & Immunology for 1-year contract assignment at AstraZeneca in Gothenburg.

Are you a scientist with expertise in drug discovery? Would you like to apply your expertise in a global company that follows the science and turns ideas into life-changing medicines? Then you could be the new colleague we are looking for! Join us as a Preclinical DMPK Project Lead!

We are now looking for an experienced and motivated individual to join our team as a Senior Research Scientist or an Associate Principal Scientist, depending on your level of professional experience and capabilities. You will be part of the DMPK Department within Early Respiratory & Immunology (R&I) and this position is placed at AstraZeneca's vibrant R&D site in Gothenburg, Sweden, one of AstraZeneca's three strategic science centers.
At AstraZeneca Respiratory & Immunology (R&I), we're proud to have an outstanding workplace culture that encourages innovation and teamwork. We are united by our vision to push the boundaries of DMPK science to transform ideas into medicines for R&I patients. Employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

What you'll do
The right candidate would have the possibility to join several ongoing projects and activities being developed at present in our department. Several of our activities are linked to real drug projects which are active in our pipeline, which offers a rare opportunity for the right candidate to participate in the discovery and development of the drugs of the future. The right candidate could join different ongoing projects performing different tasks, depending on own background and skills. One task is looking into previously conducted preclinical in vivo studies as well as clinical studies (by external partners) where public information is available. By means of applying pharmacokinetic and basic statistical knowledge (some extent of training can be provided), valuable information can be extracted for the benefit of several early drug discovery projects. Given the candidates profile, another task would be to develop a tool (a graphical user interface) for performing uncertainty analysis of predicted Dose to Man, where external public information can be of major importance.
We are looking for a person with both a sense for quality and details, an interest in data mining, programming and of course a profound interest in pharmacokinetics as well as pharmacology. This is an opportunity to learn how to apply the knowledge into real world data and thrive in the vibrant research site in Gothenburg.

Main Duties and Responsibilities

* Responsible for search of external and internal data on pharmacokinetics and biological response, for compounds of interest for ongoing projects. In scope is both preclinical and clinical data and sifting out information through various means.
* Responsible for assessment of panned out data through knowledge in pharmacokinetics, statistics, pharmacology and PKPD modelling.
* Contribute to the design of preclinical in vivo and in vitro studies, to answer crucial project questions.
* Deliver input to projects within agreed timelines and to the right quality to ensure that challenges are thoroughly assessed and resolved
* Apply an understanding of PK and PKPD to support/influence project progression and strategy as well as providing the framework for human dose prediction
* Prepare clear presentations related to the above for internal governance interactions
* Depending on the candidate's profile the candidate is expected to contribute to the development of a graphical user interface to perform uncertainty analysis of Dose to Man predictions

Essential for the role

* Degree/MSC in science with background in life-sciences, Pharmacy, Biology, Biochemistry, Medical Biosciences, Engineering, programming or similar
* PK and PKPD understanding (preferable with some modelling experience)
* Desirable some statistical and programming knowledge
* Excellent interpersonal skills that lead to successful collaborative working relationships and ability to work independently in cross-functional teams on a day to day basis.
* Good communication skills in English, both verbal and in writing are required
* Strong communication skills Visa mindre

Join the team at AstraZeneca in Gothenburg or working remotely

Hays Life Sciences is now looking to recruit a Global Pharmacovigilance Agreements Manager to join the team at AstraZeneca in Gothenburg or working remotely for a 1-year contract assignment.

This position will Working with the Pharmacovigilance Processes, Partnerships and Contracts (PV P,P&C) Lead, negotiating optimal safety agreements and contracts for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners).
Through the use of governance, relationship management, standardization and alignment ensure delivery in the most efficient lowest risk manner.

Job summary:

* Negotiate optimal, compliant, Pharmacovigilance (PV) Agreements for AstraZeneca whilst establishing excellent collaborations and maintaining positive working relationships with third party partners (i.e. Licensing Partners)
* Provide customers with expert advice, guidance and interpretation of matters pertaining to PV Agreements to demonstrate the value of Patient Safety as a key contributor to AstraZeneca internal and external business
* Collaborate with PS CoE, GPPS and Legal providing advice and support for commercial agreements ensuring that optimal and compliant PV obligations are included as required
* Collaborate with MC Safety Managers, providing advice and support for the creation and management of local PV Agreements
* Provide support to all LP audits as required and ensure remediation of findings.
* Coordination and ownership of the lifecycle management of the Licensing Agreements process enabling business continuity and compliance.
* Monitor standards and measures of compliance in relation to PV Agreements to support collaborations and continual improvement.

Day to day duties:
Manage own workload ensuring all tasks assigned are completed on time. Tasks may include but are not limited to:

* Negotiation and establishment of new PVAs in timelines agreed.
* Review and updates of existing PVAs.
* Management of own PVAs - including compliance.
* Support any audits or inspections as needed.
* Support any other tasks as required.

Required Skills/ Experience/ Education/ Qualifications:

* A science/pharmacy/nursing degree, or equivalent experience with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership)
* Experience in working cross-functionally
* Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues
* Thorough knowledge of the drug development process
* Good attention to detail
* Excellent written and verbal communication skills
* Proven ability to work across cultures
* Strong collaboration skills
* Strong negotiation, conflict management and interpersonal skills
* Relationship builder
* Able to work with high degree of autonomy and as a team
* Maintains high ethical standards, including a commitment to AstraZeneca values and behaviours
* Good time management
* Fluent in English
* Computer literate

Desirable Skills/ Experience/ Education/ Qualifications:

* MSC/PhD in scientific discipline
* Knowledge of new and developing regulatory and pharmacovigilance expectations
* Knowledge of existing AstraZeneca external alliances and collaborative projects
* Experience of working with third party suppliers.
* Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry Visa mindre

Modis is a staffing & recruiting company and is part of the Adecco Group, the world´s leading HR-solutions provider across 60 countries. This scale and scope ensures Modis is truly a global community. Our mission is to be the Leading Professional Services Company by finding the right match between you as a candidate and you as a customer. We are a team with various and complementary backgrounds within Life Science, Engineering and Technology. We can ensure that we understand our customer needs and we can ensure that we understand the competence-profiles of our applicants and candidates.

We are now seeking for a Senior Programming Specialist to AstraZeneca, Gothenburg. This opening is a consultant assignment for at least 6 months.

About the customer

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The Arena
Biometrics & Information Sciences (B&I) drives good design to generate data needed for quality decision making. B&I´s goal is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.
Programming is the department that oversees and delivers the programming aspects of clinical drug development, manages and maintains the end-to-end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure

Tasks and responsibilities/The role:
As a member of B&I Programming, collaborates with the Programming Leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project, including but not limited to the following:
• Data submission strategy (e.g., managing legacy data, pooling data)
• Responses to regulatory agency queries
• Tables Figures and Listings (TFLs)
• Development Safety Update Reports (DSURs)
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Investigators brochures (IBs)
• Office of Scientific Investigations (OSI) data sets and listings
• Regulatory and/or Payer submission related analysis data sets and/or TFLs
• Associated quality and process documentation as per applicable business processes
• Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data sets
• Pharmacokinetics/pharmacodynamics data preparation and analysis
• Manipulating and analyzing adjudicated data
• Data preparation and analysis for Global Medical Affairs work
• Clinical Trial Transparency deliverables (data de-identification, results posting files)
• Timely upload of documents to eTMF
• Produce and maintain the technical database standards and Programming Specification
documents.
• Contributes to and/or lead aspects of the provision of technical consulting expertise to external
partners in relation to the specifications and delivery of the SDTM and ADaM databases by these
partners.
• Contributes to and/or lead the development of best practice to improve quality, efficiency and
effectiveness.
• Identify opportunities to improve the methodology and provide practical solutions for problems.

Minimum requirements:
• BSc in mathematics, statistics, engineering, computer science, or life or social sciences.
• Advanced SAS programming knowledge and experience.
• Knowledge of database set-up and report publishing requirements.
• Advanced knowledge of technical and regulatory requirements related to the role.
• Knowledge of CDISC standards (e.g., CDASH, SDTM, ADaM) and industry best practices.
• Advanced knowledge and experience of clinical drug development or healthcare.
• Develop and deliver training.
• Able to demonstrate team working and role leadership skills appropriate to level.

Desirable
• Advanced verbal, written, communication and collaboration skills.
• Advanced problem solving and conflict resolution.
• Helps drive others to work across global & functional boundaries.
• Travel – willingness and ability to travel domestically and/or internationally.
• Ability to apply programming knowledge and skills to problems and quality focus. Troubleshoots
for team.
• Contributes to defining business processes and accurately completes and manages associated
documentation.
• Team commitment: prioritize attendance at appropriate project team meetings; take steps to
understand and appreciate the roles, skills and strengths of others on the team.
• Diligence – attention to detail and ability to manage concurrent projects and activities within
those projects.

Please submit your application already today, or by latest 2019-05-08 by attaching your CV and personal letter in English (interviews are held continuously).

If you have any questions about the assignment, do not hesitate and contact Markus Dahl ([email protected]). Visa mindre