Associate Director, Specialist Open-Source Developer, Clinical Data and Insights

3 tygodni temu

Warsaw, Polska AstraZeneca Pełny etat

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-2024

Closing Date

30-cze-2024

  • Clinical Data Associate/Senior Clinical Data Associate

    2 tygodni temu

    Warsaw, Polska Precision Medicine Group Pełny etat

    Precision 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...

  • Associate Director Standards Developer

    1 miesiąc temu

    Warsaw, Polska AstraZeneca Pełny etat

    The Associate Director Standards Developer is primarily responsible for leading the technical development, management and maintenance of AZ end-to-end Clinical Analysis & Reporting Standards activities in their area of expertise ( clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness,...

  • Associate Director Standards Developer

    4 tygodni temu

    Warsaw, Polska AstraZeneca Pełny etat

    The Associate Director Standards Developer is primarily responsible for leading the technical development, management and maintenance of AZ end-to-end Clinical Analysis & Reporting Standards activities in their area of expertise ( clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness,...

  • Associate Director, Clinical Document Anonymization Technology, Clinical Trial Transparency

    4 tygodni temu

    Warsaw, Polska AstraZeneca Pełny etat

    Location : 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

    7 dni temu

    Warsaw, Polska Equinix Pełny etat

    Who are we?Equinix is the world’s digital infrastructure company®, operating over 250 data centers across 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...

  • Manager, Clinical Data Programming

    4 tygodni temu

    Warsaw, Polska IQVIA Pełny etat

    Job Description : Provide line and functional management of Data Management technical experts, with a team size of around 15-20 people. Manage and prioritize resource assignments, as well as workload management across Technical Design and SAS Programming teams ensuring project milestones are met according to agreed timelines with high quality.  ...

  • Manager, Clinical Data Programming

    4 tygodni temu

    Warsaw, Polska IQVIA Pełny etat

    Job Description : Provide line and functional management of Data Management technical experts, with a team size of around 15-20 people. Manage and prioritize resource assignments, as well as workload management across Technical Design and SAS Programming teams ensuring project milestones are met according to agreed timelines with high quality.  ...

  • Principal Open-Source Program Manager

    1 miesiąc temu

    Warsaw, Polska Equinix Pełny etat

    Who are we? Equinix is the world’s digital infrastructure company®, operatingover 250 data centers across 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...

  • Principal Open-Source Program Manager

    4 tygodni temu

    Warsaw, Polska Equinix Pełny etat

    Who are we? Equinix is the world’s digital infrastructure company®, operatingover 250 data centers across 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...

  • Open-source Community Builder

    4 tygodni temu

    Warsaw, Polska Robotec.ai Pełny etat

    Robotec.ai is a software company that empowers the development of simulation platforms for robotics applications. Our Simulation and Robotics teams deliver ROS2-enabled, scalable simulation solutions for automotive, agriculture, manufacturing, logistics, mining & construction. Our Driver Monitoring Team provides data for training and validation of Driver...

  • Open-source Community Builder

    2 miesięcy temu

    Warsaw, Polska Robotec.ai Pełny etat

    Robotec.ai is a software company that empowers the development of simulation platforms for robotics applications. Our Simulation and Robotics teams deliver ROS2-enabled, scalable simulation solutions for automotive, agriculture, manufacturing, logistics, mining & construction. Our Driver Monitoring Team provides data for training and validation of Driver...

  • Associate Director, Statistical Programming

    4 tygodni temu

    Warsaw, Polska AstraZeneca Pełny etat

    Associate Director, Statistical Programming, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead a Programming team,...

  • Associate Director, Statistical Programming

    4 tygodni temu

    Warsaw, Polska AstraZeneca Pełny etat

    Associate Director, Statistical Programming, Late Stage Respiratory & Immunology Location : Warsaw (PL) Salary: Competitive, with excellent benefits. Hybrid model of work : 3 days in office, 2 days remote per week Reporting to: Director, Statistical Programming (Late Stage Respiratory & Immunology) Would you like to lead a Programming team,...

  • Pharmacovigilance Scientists

    4 tygodni temu

    Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etat

    Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK...

  • Pharmacovigilance Scientists

    1 miesiąc temu

    Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etat

    Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director Positions in GSK Safety Evaluation and Risk Management (SERM) - Specialty Safety Business. Exciting opportunities to make a significant impact on patients’ lives Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK...

  • Clinical Research Associate

    4 tygodni temu

    Warsaw, Polska MSD Pełny etat

    Job 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

    1 miesiąc temu

    Warsaw, Polska MSD Pełny etat

    Job 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...

  • Pharmacovigilance Scientists

    2 tygodni temu

    Warsaw, Polska 1925 GlaxoSmithKline LLC Pełny etat

    We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright,...

  • Director, Statistical Programming

    2 tygodni temu

    Warsaw, Polska AstraZeneca Pełny etat

    Director, Statistical Programming Hybrid work, Warsaw Are 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...

  • Associate Clinical Research Associate

    4 tygodni temu

    Warsaw, Polska MSD Pełny etat

    Job 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...