Senior Statistical Programmer

vor 18 Stunden

Wien, Österreich IQVIA Vollzeit

Vienna, Austria | Full time | Home-based | R1453558
- **Job available in additional locations**

The Senior Statistical Programmer is responsible for providing leadership and hands-on support in the development and maintenance of the statistical programming capabilities which is required to meet regulatory obligations. The individual will work closely with the Associate Director, Director, and Statistical Programmers to build internal programming tools. This individual will be responsible for review datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. This individual will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.

**Main Responsibilities and Accountabilities**:

- Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content.
- Collaborates with study teams to ensure the quality and accuracy - thus submission readiness - of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml).
- Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data.
- Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
- Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.
Works closely with clinical study teams to plans and executes activities to ensure project timelines are met with high quality deliverables.

** Additional tasks**:

- Collaborates with CR&D staff regarding data analysis requests.
- Performs additional statistical analyses including but not limited to:

- Support responses to regulatory agencies,
- Generate integrated summary of safety and efficacy,
- Support publications and presentations,
- Support planning and reporting of clinical trials via exploratory analyses of available data,
- Replicate CRO and CSL statistician analyses for QC

Position Qualifications and Experience Requirements:
**Education**
- BSc in Computer Science, Mathematics, Statistics or related area with relevant experience

Experience**
- At least 5+ years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
- In depth understanding of clinical programming and/or statistical programming processes and standards.
- In depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
- Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills.
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
- Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent).
- Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
- Experience in working in cross-functional, multicultural and international clinical trial teams.

  • Associate Statistical Data Analyst(P2)

    vor 2 Wochen

    Wien, Österreich International Atomic Energy Agency Vollzeit

    Associate Statistical Data Analyst(P2) - (2025/0221 (018658)) Organization: SGIM-Nuclear Fuel Cycle Analysis Section Primary Location: Austria-Vienna-Vienna-IAEA Headquarters Job Posting: 2025-04-16, 3:18:30 AM Closing Date: 2025-05-06, 4:59:00 PM Duration in Months: 36 Contract Type: Fixed Term - Regular Probation Period: 1 Year Full Competitive...

  • Team Leader

    vor 2 Wochen

    Wien, Österreich International Atomic Energy Agency Vollzeit

    Team Leader (Statistical Analysis)(P5) - (2025/0438 (010193)) Organization: SGIM-Nuclear Fuel Cycle Analysis Section Primary Location: Austria-Vienna-Vienna-IAEA Headquarters Job Posting: 2025-08-08, 7:55:03 AM Closing Date: 2025-08-28, 4:59:00 PM Duration in Months: 36 Contract Type: Fixed Term - Regular Probation Period: 1 Year Full Competitive...

  • Senior Programme Manager

    vor 2 Wochen

    Wien, Österreich Saffron Brand Consultants Vollzeit

    **The role**: We are looking for a Senior Programme Manager who is eager to develop with us and grow their skills by working with global clients on exciting and challenging projects. Reporting to the Chief Client Officer. **What you will do**: - Manage programmes alone and/or alongside a Programme Director, depending on their size. - Responsible for...

  • Communications/programme Assistant

    vor 2 Wochen

    Wien, Österreich OSCE Vollzeit

    Background: The OSCE has a comprehensive approach to security that encompasses politico-military, economic and environmental, and human aspects. It therefore addresses a wide range of security-related concerns, including arms control, confidence - and security-building measures, human rights, combating human trafficking, national minorities, democratization,...

  • Trainee-programm

    Vor 7 Tagen

    Wien, Österreich GoStudent GmbH Vollzeit

    Vienna - German - m/w/d **Perks**: Flexibility Fast-Track-Career Team Events Bei GoStudent arbeiten wir voller Motivation und Leidenschaft an unserer Mission, die Nummer 1 globale Schule aufzubauen! Unser Ziel ist es, dass jedes Kind weltweit sein volles Potenzial entfalten kann - durch leistbaren Unterricht in Top-Qualität mit den motiviertesten und...

  • Language Services Programme Officer(P4)

    Vor 7 Tagen

    Wien, Österreich International Atomic Energy Agency Vollzeit

    Language Services Programme Officer(P4) - (2024/0540 (018585)) Organization: MTCD-Language Services Support Section Primary Location: Austria-Vienna-Vienna-IAEA Headquarters Job Posting: 2024-09-11, 8:19:34 AM Closing Date: 2024-10-02, 4:59:00 PM Duration in Months: 36 Contract Type: Fixed Term - Regular Probation Period: 1 Year Full Competitive Recruitment:...

  • Programme Support Associate

    Vor 7 Tagen

    Wien, Österreich Iom Usrap Dc Vollzeit

    Context The IOM Country Office for Austria works on a number of different topics such as research and migration law; labour mobility & social Inclusion; migrant protection, including of trafficked persons and migrant children, family reunification, assisted voluntary return and reintegration, visa support and refugee resettlement. The Programme and Policy...

  • Programme Support Coordinator

    Vor 7 Tagen

    Wien, Österreich International Organization for Migration Vollzeit

    Position Title**: Programme Support Coordinator** Duty Station**: Vienna, Austria** Classification**: Professional Staff, Grade P3** Type of Appointment**: Special short-term graded, Six months with possibility of extension** Estimated Start Date**: As soon as possible** Closing Date**: 22 October 2024** - Established in 1951, IOM is a Related Organization...

  • Programme Officer, Energy Security

    vor 2 Wochen

    Wien, Österreich OSCE Vollzeit

    Background: This position is open for secondment only and participating States are kindly reminded that all costs in relation to an assignment at the Secretariat must be borne by their authorities. The OSCE has a comprehensive approach to security that encompasses politico-military, economic and environmental, and human aspects. It therefore addresses a...

  • Graduate Programm in Small

    vor 2 Wochen

    Wien, Österreich HypoVereinsbank - UniCredit Vollzeit

    **Die UniCredit Bank Austria ist die führende Bank in Österreich und Teil des UniCredit-Netzwerks. Wir sind eine moderne Universalbank und bieten Leistungen und Produkte für Privatkund:innen, Klein - und Mittelbetriebe, Private-Banking-Kund:innen, Großunternehmen und für die öffentlichen Hand an. Und wir investieren konsequent in die Qualifikation und...