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Biostatistician

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Support, Design

Projektbeschreibung

Key Responsibilities:

- Support/participate in the development of clinical program.
- Review protocols and CRFs for soundness of trial design.
- Write statistical methodology section of the protocol.
- Prepare analysis plan and programming specifications
- Perform inferential analyses; inputs to the statistical section

of the clinical study report and review clinical study report
- Support/participate in project related activities including

preparation of BLA submissions and oversee CRO deliverables for
studies contracted out.

Requirements:

- PhD and at least 2 years of biopharmaceutical experience or a MS

with at least 5 years of experience are required.
- The successful candidate will also possess strong statistical and

data analysis skills
- Strong knowledge of statistical and clinical trial methodology.
- Solid hands-on experience as statistician in clinical development

program.
- Good knowledge of drug development process, and experience in

supporting BLA submissions.
- Strong ability in protocol development, analyses and clinical

trial reports/publications of clinical trials.
- Excellent oral and written communication skills
- Knowledge of FDA/ICR guidelines; good knowledge of SAS, S-Plus

(or R) computer packages.
- Good project management skills are also required.

Responsibilities:

- With periodic supervision and guidance from senior departmental

staff, provide support and leadership to a clinical study team on
all relevant statistical matters.
- Act as liaison to study team, ensuring that the clinical study is

conducted in a manner that supports planned statistical analysis.
- With some supervision and guidance from senior departmental

staff, design clinical study and help produce protocol or
amendments. Perform relevant sample size calculations.
- Develop statistical analysis plan (SAP).
- Work with programming team to provide definitions, documentation,

and review of derived variables needed to produce planned TFL.
- Perform statistical analysis defined in SAP, prepare statistical

methods and results sections for the clinical study report (CSR),
and work with the study team to move the CSR through review and
approval process.
- Provide statistical insight into interpretation and discussion of

study results.
- Produce / coordinate production of statistical summaries,

analyses, annual reports, and related materials for submission to
regulatory authorities or independent monitoring committees.
- Provide assistance to project biostatistician or Therapeutic Area

lead biostatistician in project activity and timeline tracking,
resource planning, and preparation of scientific reports or
position papers.

Experience and Required Skills:

Technical Skills:

- SAS, S-Plus (or R), Sample size calculation software, and MS

Office.

Core Competencies:

- Must be able to work in a consistently busy environment
- Flexibility and multi-tasking are highly desirable skills for

this position.
- Written and oral communication Skills
- Research Experience a plusTo find out more about Real Staffing please visit www.realstaffing.com

Projektdetails

  • Einsatzort:

    Parsippany-Troy Hills, New, Jersey

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland