Senior Statistician

  • Munich, Germany
  • Full-time

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.  A dynamic, global company founded in 1995, we bring together more than 1,700+ 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

    Reporting to the Director of Biostatistics, the Senior Statistician is an integral part of our team here at PSI. If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods, apply today!  

    Primary Responsibilities:

    • Leading all biostatistics activities related to clinical trials as responsible project statistician
    • Communication line for project teams, clients and vendors on statistical questions
    • Development and review of statistical sections of protocols, including sample size calculations
    • Development of statistical analysis plans
    • Development and documentation of analysis database structures (i.e. SAS analysis data set structures)
    • Development of SAS program requirements and specifications
    • SAS programming and program validation
    • Review and QC of statistical deliverables (tables, listings, figures, etc.)
    • Performing statistical analysis and reporting results
    • Providing consultation on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products
    • Liaison with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics

    Corporate/Departmental Assignments

    • Participation in bid defense meetings and kick-off meetings
    • Communication line for project teams, including statisticians and SAS Programmers
    • Communication line for customer on statistical questions
    • Communication line for vendors on statistical questions

    Training

    • Conduct of project-specific training of statisticians and SAS programmers
    • Coaching and training of statisticians (non-project-related)
    • Preparation and delivery of presentations at investigators' meetings

    Quality Assurance

    • Preparation for and attendance at internal and third-party study audits pertinent to Statistics
    • Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings
    • Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department  

    Qualifications


    Minimum Education:

    • MSc in Statistics or equivalent

    Experience:

    • Strong industry experience in clinical research, biostatistics and SAS programming
    • Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
    • Very good knowledge and understanding of the SAS programming language
    • Strong ability to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
    • Strong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
    • Strong ability to represent biostatistics in bid defenses
    • Strong knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)

    Skills:

    • Excellent presentation and communication skills
    • Advanced knowledge of SAS software
    • Good knowledge of MS office software
    • Advanced knowledge of CDISC ADaM IG 1.0 or later, define 1-0-0.xml and define 2-0-0.xml specifications
    • Knowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plus

    Additional Information

    Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

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