Senior Biostatistician

Vor 3 Tagen

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 who need them.

**Job Description**:
Office-based or Home-based

You will:

- Lead all biostatistics activities related to clinical trials as responsible project statistician
- Communicate with project teams, clients and vendors on statistical questions
- Develop and review statistical sections of protocols, including sample size calculations
- Develop statistical analysis plans
- Develop and document analysis database structures (i.e. SAS analysis data set structures)
- Develop SAS program requirements and specifications
- SAS programming and program validation
- Review and QC of statistical deliverables (tables, listings, figures, etc.)
- Perform statistical analysis and report results
- Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
- Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics
- Participate in bid defense meetings and kick-off meetings
- Train statisticians and SAS programmers
- Prepare and deliver presentations at investigators' meetings
- Address audits findings/recommendations, and follow-up on and resolution of audit findings
- Participate in the development of guidelines, procedures

**Qualifications**:

- MSc in Statistics or equivalent
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
- Knowledge and understanding of the SAS programming language; advanced knowledge of SAS software
- Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
- Strong knowledge of CDISC ADaM IG 1.0 or later, define 1-0-0.xml and define 2-0-0.xml specifications
- Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
- Presentation and communication skills

**Please submit your CV in English.**

Additional Information

Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. Having recently been awarded five CRO Leadership Awards in 2021, this is a great time to be joining a well-respected, Global company.

  • Senior Biostatistician

    vor 3 Wochen

    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...

  • Senior Biostatistician

    vor 1 Monat

    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...

  • Senior Biostatistician

    vor 2 Wochen

    Munich, Deutschland Fortrea - Organic 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...

  • Senior Biostatistician

    vor 2 Wochen

    Munich, Deutschland Oracle Vollzeit

    Senior Biostatistician (M/F/d)-230005GS **Applicants are required to read, write, and speak the following languages***: English **Preferred Qualifications** Are you a Biostatistician who enjoys programming in SAS? If you have CDISC SDTM and ADaM experience, this is an incredible opportunity to excel in an exciting, fast-paced arena! Oracle Life Sciences...

  • Senior Biostatistician

    vor 2 Wochen

    Munich, Deutschland Hobson Prior Vollzeit

    Hobson Prior are seeking for a Senior Biostatistician to join a fantastic CRO on a permanent basis with the ability to work remotely from anywhere in Europe, apart from Switzerland, Belgium, Sweden, Denmark, Ukraine and Russia. Our client is focused on delivering pivotal phase II & III clinical trials on budget and in a timely manner for their...

  • Sr Biostatistician

    vor 3 Wochen

    Munich, Deutschland Syneos Health Clinical Vollzeit

    **Description** **Senior Biostatistician - Europe** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...

  • Senior Biostatistician

    vor 4 Wochen

    Munich, Deutschland Cerner Corporation Vollzeit

    Drive development of appropriate study protocols, research design and statisitcal analyses, consult with investigators to determine questions of interest and data necessary to answer questions. - Drive thought leadership for Cerner’s key secondary data offerings by creating and publishing health outcomes studies using the data. - Train client-facing...

  • Senior Biostatistician

    vor 6 Stunden

    Munich, Deutschland Cerner Corporation Vollzeit

    Drive development of appropriate study protocols, research design and statisitcal analyses, consult with investigators to determine questions of interest and data necessary to answer questions. - Drive thought leadership for Cerner’s key secondary data offerings by creating and publishing health outcomes studies using the data. - Train client-facing...

  • Director Biostatistics

    vor 1 Woche

    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...