Associate Director, Specialist Open-Source Developer, Clinical Data and Insights
2 tygodni temu
The Associate Director, Open-Source Developer, is responsible for ensuring the high-quality, timely, and efficient development of open-source infrastructure for clinical programming and effective information management. This pivotal role demands profound experience in Python, R, and SAS programming, coupled with excellent industry knowledge of creating open-source programming capabilities for GxP usage. It will initiate and lead a cross-functional team for process improvements.
In the pharmaceutical industry, reporting has traditionally been conducted using SAS. However, as we expand our technology, we are eager to build innovative tools utilizing open-source programming to bolster Biometric activities. We are seeking expertise in R and other open-source tools that can streamline the process of data analysis and usage within these functions. This position will be instrumental in driving the business architecture for R and open-source tools for GxP activities.
Main Duties and Responsibilities:
Innovate the application of computer science and information technology to develop and maintain cutting-edge tools that support advanced analysis and foster innovation within the Clinical Data and Insights domain, pushing the boundaries of what's possible. Engage in best practices, driving continuous improvement to elevate quality, efficiency, and effectiveness within the function, setting new benchmarks for excellence. Demonstrate unparalleled programming expertise, constantly evolving and staying ahead of best practices and emerging developments, ensuring a leading-edge approach to all programming activities. Architect and define the strategic utilization of open-source tools across AstraZeneca, envisioning and implementing the blueprint for open-source usage that sets the standard for the industry. Additionally, technically deliver on this blueprint, ensuring that the implementation aligns with the strategic vision and delivers tangible, high-impact results. Serve as a Subject Matter Expert in open-source development, articulating and championing pivotal initiatives across departments and functions, empowering the organization to embrace and execute innovative strategies. Revolutionize operational methodologies, fostering an environment of continuous improvement to amplify innovation and drive the organization to new heights of excellence. Act as the ambassador of AstraZeneca and its values at both internal and external events, embodying and promoting the company's commitment to innovation, excellence, and integrity. Ensure unwavering compliance with computer system validation, ensuring that all tools are developed to be audit-ready, setting the gold standard for compliance and quality assurance.Essential Requirements:
Bachelor's degree from a reputable and accredited university in Computer Science, Data Science, Statistics, Information Technology, or other STEM-related fields, coupled with hands-on experience working with and developing open-source infrastructure specifically for regulatory submissions within the pharmaceutical or other regulated industry. Proven track record of leading and implementing open-source programming capabilities for GxP usage, showcasing an advanced proficiency in Python, R, and SAS, and a robust portfolio of successful projects that highlight the ability to deliver high-impact solutions, particularly in the context of regulatory submissions. Extensive experience in R package development, validation, and life cycle management, along with a demonstrable ability to architect and support R infrastructure within a highly regulated environment, ensuring compliance with industry standards and regulations. In-depth knowledge and practical application of data structures aligned with CDISC standards, such as vectors, matrices, and data frames, enabling the rapid and efficient development of innovative solutions that comply with regulatory requirements. Exceptional understanding of compliance principles and standards, ideally supported by direct experience in ensuring computer system validation compliance for audit-ready state, demonstrating meticulous attention to detail and a commitment to upholding the highest standards of quality and regulatory compliance. Proven ability to drive the strategic design and architecture of open-source technologies within a complex organizational landscape, delivering on the technical blueprint and ensuring the successful implementation of solutions aligned with the strategic vision, particularly within the context of regulatory submissions. A strong portfolio of successful initiatives that have driven innovation, improved ways of working, and enhanced operational effectiveness within a clinical data or biometrics function, with a specific focus on regulatory submission processes. Outstanding communication and collaboration skills, with a proven ability to act as a source of knowledge, defining and communicating important initiatives across departments and functions, and representing the organization at internal and external events, particularly in the context of regulatory and compliance matters. Proactive mindset, with a track record of truth-seeking rather than success-seeking, embracing peer review, and driving a culture of continuous improvement and innovation, with a specific emphasis on regulatory compliance and best practices within the pharmaceutical industry.Desirable Requirements:
Proficiency in statistical software and methodologies, with a MS in biostatistics, bioinformatics, statistics, or a related field, enabling advanced analysis and interpretation of complex clinical data sets, and contributing to the development of innovative statistical approaches within the context of open-source infrastructure for regulatory submissions. Proficiency in additional programming languages such as Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, or others, enabling a broad spectrum of technical capabilities and a comprehensive approach to open-source development. Proven ability to mentor and train team members, fostering a culture of continuous learning and development within the organization, particularly in the context of open-source technologies and regulatory compliance.Date Posted
11-cze-2024Closing Date
30-cze-2024-
Clinical Data Associate/Senior Clinical Data Associate
2 tygodni temu
Warszawa, Mazovia, Polska Precision Medicine Group Pełny etatPrecision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific...
-
Clinical Data Associate/Senior Clinical Data Associate
2 tygodni temu
Warszawa, Mazovia, Polska Precision for Medicine Pełny etatPrecision for Medicine is seeking an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. Under direct supervision, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific...
-
Warszawa, Mazovia, Polska AstraZeneca GmbH Pełny etatLocation: Warsaw (PL)Salary: Competitive, with excellent benefits.Hybrid model of work : 3 days in office, 2 days remote per weekThis role sits within the Clinical Document Anonymisation and Data Sharing function in Clinical Trial Transparency, Chief Medical Office. The Clinical Trial Transparency leads the AstraZeneca Group of Companies, Clinical Trial...
-
Warszawa, Mazovia, Polska AstraZeneca Pełny etatLocation : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week This role sits within the Clinical Document Anonymisation and Data Sharing function in Clinical Trial Transparency, Chief Medical Office. The Clinical Trial Transparency leads the AstraZeneca Group of Companies,...
-
Principal Open-Source Program Manager
2 tygodni temu
Warszawa, Mazovia, Polska Equinix, Inc. Pełny etatWho are we?Equinix is the world's digital infrastructure company, operating over 250 data centersacross the globe. Digital leaders harness Equinix's trusted platform to bring together and interconnect foundational infrastructure at software speed. Equinix enables organizations to access all the right places, partners and possibilities to scale with agility,...
-
Warszawa, Mazovia, Polska Worldwide Clinical Trials, LLC Pełny etatWho we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on...
-
Scientist, Clinical Trial Safety
2 tygodni temu
Warszawa, Mazovia, Polska AstraZeneca Pełny etatABOUT DEPARTMENT The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. The primary remit of the TRISARC is to review large amounts of clinical (mainly safety) data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing...
-
Associate Director, Statistical Programming
2 tygodni temu
Warszawa, Mazovia, Polska AstraZeneca Pełny etatAssociate Director, Statistical Programming, Late Stage Respiratory & ImmunologyLocation: Warsaw (PL)Salary: Competitive, with excellent benefits.Hybrid model of work: 3 days in office, 2 days remote per weekReporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology)Are you ready to lead a programming team with a direct strategic...
-
Clinical Research Associate
2 tygodni temu
Warszawa, Mazovia, Polska Johnson & Johnson Pełny etatJob Description - Clinical Research Associate (Site Manager W) Clinical Research Associate (Site Manager W Description Position Summary:A Site Manager I (SM I) serves as the primary contact point between the Sponsor and the Investigational Site.A Site Manager I is assigned to trial sites to ensure inspection readiness through compliance with the...
-
Associate Clinical Research Associate
4 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionIf you want to: Join a multi-award-winning leading biopharmaceutical company Be part of growing team of Clinical Research Associates Use new technology and smart monitoring tools Have flexibility of work and good work-life balance Apply today On this position you will be accountable for performance and compliance for assigned protocols and...
-
Associate Clinical Research Associate
2 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionIf you want to: Join a multi-award-winning leading biopharmaceutical company Be part of growing team of Clinical Research Associates Use new technology and smart monitoring tools Have flexibility of work and good work-life balance Apply today On this position you will be accountable for performance and compliance for assigned protocols and...
-
Associate Clinical Research Associate
4 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob DescriptionIf you want to: Join a multi-award-winning leading biopharmaceutical company Be part of growing team of Clinical Research Associates Use new technology and smart monitoring tools Have flexibility of work and good work-life balance Apply today On this position you will be accountable for performance and compliance for assigned protocols and...
-
Clinical Research Associate
1 miesiąc temu
Warszawa, Mazovia, Polska MSD Pełny etatJob Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.If you want to: Join a multi-award-winning...
-
Clinical Research Associate
2 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.If you want to: Join a multi-award-winning...
-
Clinical Research Associate
4 tygodni temu
Warszawa, Mazovia, Polska MSD Pełny etatJob Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.If you want to: Join a multi-award-winning...
-
Medical Director
2 tygodni temu
Warszawa, Mazovia, Polska Sitero LLC Pełny etatMedical DirectorSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical...
-
People Services Associate
2 tygodni temu
Warszawa, Mazovia, Polska Worldwide Clinical Trials Pełny etatRequisition Number: 8017 Position Title: People Services Associate External Description: Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to...
-
Warszawa, Mazovia, Polska AstraZeneca Pełny etatStatistical Programming Associate Director, Late Stage Respiratory & ImmunologyLocation: Warsaw (PL)Salary: Competitive, with excellent benefits.Hybrid model of work: 3 days in office, 2 days remote per weekReporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology)Excited about leading clinical studies with a direct strategic...
-
Director, Statistical Programming
2 tygodni temu
Warszawa, Mazovia, Polska AstraZeneca GmbH Pełny etatDirector, Statistical ProgrammingHybrid work, WarsawAre you an experienced Statistical Programmer with good knowledge of clinical drug development and leadership? Would you like to be part of a fast-paced and agile global team that has direct strategic impact on drug development, empowered and trusted to innovate and experiment? Join us at AstraZeneca CVRM...
-
In-house Clinical Research Associate II – EMEA – Home based
2 tygodni temu
Warszawa, Mazovia, Polska Worldwide Clinical Trials, LLC Pełny etatWho we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular,...
