Biostatistician, Real World Evidence

hace 2 semanas

Barcelona, Barcelona, España IQVIA A tiempo completo

ob OverviewWith appropriate support and guidance: prepare analysis plans and write detailed specifications for analysis files, tables, listings and figures, interpret analyses and write statistical sections of study reports.

Develop and maintain programs to meet internal and external clients' needs. Provide training, guidance and mentorship to lower level and new staff.
Essential Functions

Production of High-Quality Deliverables:
Completes assigned tasks with focus on checking own work for accuracy. Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken. Checks programming logs for cleanliness and correct processing of data. Inputs into Data Issues log and follows issues to appropriate resolution.

Leadership:

Demonstrates awareness of other functions and their processes with respect to Biostatistics role in the project and acts accordingly, including management of data quality issues and resolution.

Provide best in class solutions to Biostatistics and Programming challenges.

Datasets:

With appropriate support and guidance, programs datasets to industry standards, maximizes programming efficiency with use of tools where applicable.

Handles analysis set derivations and assignment, under supervision as needed.

  • Tables, Listings and Figures (TLFs): Programs TLFs and maximizes programming efficiency with use of tools, where applicable. Checks resulting output for format and content, and questions specification as needed. Ensures consistency across items produced.

Timelines:

Accountable for delivering own work within agreed timeframe and for identifying in a timely manner if a task takes longer than expected to complete.

Provides regular and timely progress updates, shows awareness of how own progress impacts the wider team. Under supervision, plans and documents timelines, discusses forecast resource needs.

Scope:
Has a basic understanding of 'scope of work' and budget assumptions.

If new work or re-work appears to be Out of Scope, raises with Project Team Lead(s) in a timely manner.


Risk Management:

Identifies risks to project delivery and/or quality to Project Team Leads and line manager, makes suggestions to mitigate risks.


Knowledge Sharing:
May mentor junior staff, provides knowledge sharing through presentation/ discussion at team/ department meetings. Actively participates in project team meetings. May help train 'new to IQVIA' staff regarding operational items.

  • Under Supervision

Leadership:

Under close supervision, may take the role of Statistical Team Lead for a single study or parts of a study.

Through this, works closely with the Project Team Lead and supervisor, to deliver on time, with high quality and within budget.


Tasks include but are not limited to:
Develops an efficient programming strategy, utilizing available tools and creation/ maintenance of project specific macros, ensures SOP compliance. Demonstrates and promotes efficient communication. If in lead role, runs meetings, documenting where necessary and following up on actions. Actively participates in internal project team meetings, provides timely progress updates. As a lead, will have input on estimate at completion (EAC) reporting.

Data Management:
Assist in reviewing or advising data management staff on CRF and database design, validation checks and critical data. Handles data issue resolutions. If in lead biostatistical role, handles lock and unblinding process with appropriate supervision.

  • Statistical Analysis Plan (SAP) and Shells: May author or perform review of SAP and shells, where applicable.

Specifications:
Writes and maintains specifications for assigned datasets and TLFs, where applicable.

Technology:
Awareness and utilization of technology offerings (Biostatistical Tools) rolled out by the Global business unit. May be a contributor to development of technology offerings.

Risk Management:
Consults team lead or manager in identifying possible risks to minimize need for study level escalations.

Other Responsibilities:
May serve as primary point of contact for client. May consult on operational topics with clients. May review or draft clinical study report (CSR) and/or statistical report. May assist and contribute to request for proposal and bid defenses, where deemed appropriate.
Qualifications

  • Biostatistics or related field and 1 year relevant experience
  • Typically requires 1+ years of prior relevant experience, or Equivalent combination of education, training and experience.
  • Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
  • Strong planning and organizational skills.
  • Very good communication and interpersonal skills.
  • Ability to handle conflicting priorities and effectively manage multiple tasks and projects.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Awareness of relevant Data Standards (such as CDISC/ADaM/SDTM).
  • Aptitude for mathematical calculations and problem solving.
  • Strong software and computer skills, including Microsoft Office applications.
  • Extensive knowledge of Microsoft Excel.
  • Results and detail-oriented approach to work delivery and output.
  • Excellent customer service skills.
  • Working knowledge of Microsoft server, workstation and networking technologies.
  • Knowledge of the clinical drug development process.#LI-MH5 At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.
Learn more at Espoo, Finland; Turku, Finland; Lisbon, Portugal; Athens, Greece; Barcelona, Spain; Milan, Italy; Madrid, SpainType:
Full time

  • Real World Evidence Associate Director

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Real World Evidence Associate DirectorBarcelona, SpainAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies.Oncology is...

  • Internship Real World Evidence Solutions

    hace 2 semanas

    Barcelona, Barcelona, España Novasyte A tiempo completo

    Intern - Real World Evidence Solutions12 months FTC (Full-time Internship)Location: Barcelona or MadridJob OverviewThe main purpose of the Full-time internship in the Real World Evidence (previously known as Health Economics and Outcomes Research) department is to collaborate and support the team members during the development of the projects they are...

  • Senior Real World Evidence Scientist

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Senior Real World Evidence ScientistBarcelona, SpainAbout AstrazenecaAstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical...

  • Internship Real World Evidence Solutions

    hace 2 semanas

    Barcelona, Barcelona, España IQVIA A tiempo completo

    Intern - Real World Evidence Solutions12 months FTC (Full-time Internship)Location: Barcelona or MadridJob OverviewThe main purpose of the Full-time internship in the Real World Evidence (previously known as Health Economics and Outcomes Research) department is to collaborate and support the team members during the development of the projects they are...

  • Senior Real World Evidence Scientist

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Senior Real World Evidence Scientist:Boston US / Gaithersburg US / Macclesfield UK / Luton UK / Barcelona SpainAbout Astrazeneca:AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're...

  • Biopharmaceuticals Medical Evidence Real World Data

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Introduction to role:Join our industry-leading BioPharmaceuticals team, where our rich and diverse pipeline speaks for itself. We're evolving and accelerating - growing Respiratory, Cardiovascular and Metabolism, moving into Immunology and Renal. We are proud of our growth because of the huge potential to create impact as well as our ability to address the...

  • Biopharmaceuticals Medical Evidence Real World Data

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Introduction to role:Join us at AstraZeneca in the Biopharmaceuticals Business Unit as a Real World Data (RWD) Alliances & Governance Director. This role is a unique opportunity to shape the future of healthcare and be part of changing the practice of medicine forever. We dare to do the big studies in the real world, utilising primary and secondary data,...

  • Real World Solutions Intern

    hace 2 semanas

    Barcelona, Barcelona, España Alira Health A tiempo completo

    ABOUT ALIRA HEALTHAt Alira Health, our mission is to enable healthcare transformation. We support our clients with a technology-enabled integrated suite of Product Development, Regulatory, Clinical, Global Market Access, Real-World Evidence, Patient Engagement, Strategy Consulting, and Transaction Advisory services. Our team of scientists, strategists,...

  • Senior Manager, Heor Real World Evidence Excellence

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Senior Manager HEOR Real World Evidence Excellence Position Summary The HEOR RealWorld Evidence (RWE) Senior Manager is part of the global HEOR team. He/she will work with the RWE Centre of Excellence team, the International and Japan HEOR team, and the Medical Affairs RWE Champions in countries to support the development of the strategy, planning and...

  • Biopharmaceuticals - Associate Director, Real World

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Location: Barcelona (on-site)BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca therapies and support our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation and...

  • Biostatistician

    hace 2 semanas

    Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    Overview:TFS HealthScience is excited to be expanding our Biostatistic team and we are looking for an experienced, highly motivated Senior Biostatistician who shares our vision of providing clinical research excellence. Our Biostatistic team is a highly experienced international group of professionals led by an industry expert.We are a leading global...

  • Biopharmaceuticals Medical Evidence

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Location: Barcelona (on-site)BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca therapies, while supporting our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation...

  • Evidence Delivery Manager

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Introduction to Role:Join our BioPharmaceuticals Medical (BPM) team as an Evidence Delivery Associate Director (EDAD). Our BPM team is dedicated to providing healthcare decision-makers with the evidence they need to make informed decisions about AZ therapies. As an EDAD, you will lead or support the operational planning, delivery, oversight, and budget...

  • Biopharmaceuticals Medical Evidence

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Location: Barcelona (on-site)BioPharmaceuticals Medical (BPM) ensures the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca therapies, while supporting our internal stakeholders with medical insight and expertise. BPM provides medical leadership with market participation...

  • Biostatistician 20240054

    hace 2 semanas

    Barcelona, Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR-RRHH-FOR-003_vs01_TheVall d'Hebron Research Institute(VHIR) is a public sector institution thatpromotes and develops the research,innovation and biosanitary teaching of theVall d'Hebron University Hospital. Throughthe excellence of our research, we identifyproblems of society and we contribute tospread them around the world.In April 2015, the Vall...

  • Evidence Delivery Associate Director

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Introduction to Role:Join our BioPharmaceuticals Medical (BPM) team, where we ensure the best patient outcomes by providing healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies. We are looking for an Evidence Delivery Director (EDD) who will be responsible for the operational planning, delivery,...

  • Data Analyst Intern

    hace 2 semanas

    Barcelona, Barcelona, España Alira Health A tiempo completo

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration.Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.Job Description:REAL-WORLD...

  • Evidence Portfolio Delivery Director

    hace 2 semanas

    Barcelona, Barcelona, España AstraZeneca A tiempo completo

    Introduction to Role:Join our BioPharmaceuticals Medical (BPM) team, where we strive to provide healthcare decision-makers around the world with the evidence and confidence they need on AstraZeneca (AZ) therapies. As an Evidence Delivery Director (EDD), you will be responsible for the operational planning, delivery, oversight, and budget management of...

  • Evidence Delivery Director

    hace 2 semanas

    Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Evidence Delivery Director who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert.We are a leading global mid-size Contract Research...

  • Biostatistician-headache Clinical Unit

    hace 2 semanas

    Barcelona, Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR-RRHH-FOR-003_vs01TheVall d'Hebron Research Institute(VHIR) is a public sector institution thatpromotes and develops the research,innovation and biosanitary teaching of theVall d'Hebron University Hospital. Throughthe excellence of our research, we identifyproblems of society and we contribute tospread them around the world.In April 2015, the Vall...