Expert Statistical Programming

vor 4 Wochen


Munich, Deutschland Daiichi Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.

Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.

We are currently looking for a

**Expert Statistical Programming (M/F/x)**:
**The position**:
The position holder will support end-to-end delivery of Statistical Programming services for assigned
studies, collaborating with CROs and other vendors to ensure high quality deliverables are on
time and within budget.
The position holder will support study lead and partner with internal and external stakeholders to
optimize Statistical Programming technology, processes, and standards.
standards, and fundamental technical skills in working with data received from CROs and other thirdparty
vendors.

**Roles & responsibilities**:

- Study level statistical activities
- Responsible, with supervision, for operational aspects of study activities assigned to Statistical Programming
- Including but not exclusive to SAPs and TFL shells review from a programming perspective,
- Limited contribution to develop SDTMs and ADaM datasets specifications, contribute to develop
- SAS programs to create SDTM and ADaM datasets and TFLs based upon provided specs
- Ensure timely and accurate completion of Statistical Programming deliverables
- Must comply with international regulations and maintain inspection readiness
- Ensure inspection readiness as well as prepare potential audits linked to assigned studies
- Vendor Oversight
- With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with
the protocol, external/internal standards applicable regulatory guidelines, policies, SOPs, and other
relevant guidelines.
- Participates in drafting request for proposal for CRO selection.
- Reviews base-line budget and timelines.
- Contributes to budget management and activities across the project duration
- Operational Excellence Innovation
- Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions
- Maintains current knowledge of industry best practice in Statistical Programming methodology

Any other duties deemed pertinent to the needs of the business.

**Professional experience & education**:

- Education and Experience
- Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
- No previous experience mandatory
- Competencies and Generic Skills
- Excellent English language skills
- Understanding of GCP and GDPR principles
- Good communication skills, both oral and written, in explaining in simple terms complex concepts
- Knowledge of SAS language, procedures and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
- Baseline knowledge of advanced statistical methods using SAS
- R knowledge is highly preferred but not required
- Knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.
- Ability and interest to work remotely with worldwide team members across cultures and time zones

**Why work with us?**:



  • Munich, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading...


  • Munich, Deutschland TruMinds Technologies Vollzeit

    **Key responsibilities and skills may include, but are not limited to**: - Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. - Develop SDTM specifications and generate SDTM datasets using SAS. - Develop ADaM, specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. - Develop Tables, Listings,...


  • Munich, Deutschland Freudenberg Vollzeit

    Working at Freudenberg: We will wow your world! Responsibilities: Development of and participation in data-based projects with a focus on research and development (R&D) Development and use of expert knowledge on the application of artificial intelligence (in particular machine learning) in R&D Supporting the (further) development of...


  • Munich, Deutschland Freudenberg Group Vollzeit

    Working at Freudenberg: We will wow your world! **Responsibilities**: - Development of and participation in data-based projects with a focus on research and development (R&D)- Application of statistical tools, such as Design of Experiments, to investigate and optimize product properties as well as measurement and production processes- Identification of...


  • Munich, Deutschland Hobson Prior Vollzeit

    **Salary**: €80000 - €85000 per annum**Job type**: Permanent **Location**: München (81379), Deutschland **Function**: Biometrics, Statistical Programming **Posted**:02/04/2024 **Ref**: BBBH25005 - Hi I'm Antony , I manage this role Please note that to be considered for this role you must have the right to work in this location. **Key...


  • Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...


  • Munich, Deutschland Baumlink Vollzeit

    For a global energy firm: Your tasks: - Your main focus is the development of statistical methods for the validation of margin and risk models - Further development of internal validation processes. - You work with senior management, regulatory authorities, and control bodies to improve service Your profile: - Understanding of statistical methods for the...

  • Statistical Lead

    Vor 2 Tagen


    Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

    **Your Role**: - Member of the medical team, with key role leading the biostatistics activities for clinical development (Phase I to Phase IV) - Responsible for providing all statistical inputs for study design, outcome measurement, data collection, endpoint assessment, sample size and power calculation, including coordinating external statistician expert...


  • Munich, Deutschland Staburo GmbH Vollzeit

    **Your responsibilities will include**: - Analysis of project data (e.g. trial data) and data processing - Statistical programming with SAS, development of reusable programs (e.g. macros), data visualization, and output generation - Specification and creation of analysis datasets - Validation of datasets and outputs - Support non-clinical / clinical...


  • Munich, Deutschland Fortrea Vollzeit

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Munich, Deutschland MAI Fortrea Development Limited Vollzeit

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: We're seeking a seasoned scientist with a track record in human/animal genetics research, particularly in fibrotic diseases, cardio-renal-metabolic diseases, cancer immunology and oncology. You will leverage your expertise in genetic and genomics data to drive breakthroughs in new therapeutic concepts, and your experience in analyzing...


  • Munich, Deutschland Fortrea Vollzeit

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Munich, Deutschland MAI Fortrea Development Limited Vollzeit

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Munich, Deutschland PSI CRO Vollzeit

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those...

  • Post Doc

    vor 9 Stunden


    Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: This position is part of the Statistics team that is globally responsible to support the BioPharma network comprising sites in Germany, Austria, USA, and China. Statistical topics cover the complete value chain of the biopharmaceutical production process at different stages from development, launch and life cycle. You are part of a...

  • Trainee Biostatistics

    vor 1 Monat


    Munich, Deutschland Staburo GmbH Vollzeit

    **Your responsibilities will include**: - Evaluation of clinical studies of phases I - IV and presentation of the results - Statistical programming (SAS with SDTM and ADaM; R) - Program validation of clinical trials - Support of the statistics department - Participation in SAPs and study designs **Your profile**: - Successfully completed or nearly...


  • Munich, Deutschland BI Pharma GmbH&Co.KG Vollzeit

    **The Position**: Are you looking for an exciting challenge during your studies in an internationally successful company that has been awarded as one of the “Global Top Employers” several times? Do you want to apply, deepen, and expand your acquired knowledge in practice? As the world leader in the production of innovative medicines, we at Boehringer...

  • Hpc Specialist

    Vor 5 Tagen


    Munich, Deutschland Leibniz-Rechenzentrum (LRZ) Vollzeit

    **HPC Specialist (f/m/d) for Parallel Programming Environments and Libraries** - **Your Role and Responsibilities**:_ - Installation, quality and performance verification of communication and message-passing libraries (MPI, Global Arrays, OpenShmem, OpenCoarrays etc.) on the LRZ HPC systems. - Setting up tools, workflows and further development of a test...

  • Hpc Specialist

    Vor 5 Tagen


    Munich, Deutschland Leibniz-Rechenzentrum (LRZ) der Bayerischen Akademie der Wissenschaften Vollzeit

    You are looking for an employer you can count on? Join us! **HPC Specialist (f/m/d)** **for Parallel Programming Environments and Libraries **_Your Role and Responsibilities: _** - Installation, quality and performance verification of communication and message-passing libraries (MPI, Global Arrays, OpenShmem, OpenCoarrays etc.) on the LRZ HPC systems. -...