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Statistical Consultant

Eingestellt von Synectics

Gesuchte Skills: Support, Consultant

Projektbeschreibung

RESPONSIBILITIES

- Serves as the Study/Project Biostatistician.
- Provides statistical support for protocol development including the sample size calculations, statistical analysis plan (SAP) preparation, and statistical analysis of clinical study data and presents them in the study report and publications, ensuring that the study design is appropriate, and that appropriate statistical methodologies are used.
- Manages submission-related statistical activities such as generating pooled study analyses for the summary reports.
- Utilizes statistical knowledge and expertise to provide statistical support for clinical studies.
- Participates in protocol development and ensures appropriateness of study design, sample size and proposes appropriate statistical methodologies.
- Authors the Statistical Analysis Plan for the protocol.
- Performs/reviews statistical analysis, interpreting analyses results, and writing/reviewing the corresponding sections of the clinical study report (CSR).
- Oversees the generation of all statistical appendices.
- Reviews other sections of the CSR as appropriate.
- Participates in the process of CRF design and development, ensuring that it meets the protocol criteria and captures all data required to support the planned analysis.
- Creates mock-ups, reviews, and approves tables, listings and graphs specifications.
- Actively participates in project/study team meetings.
- Establishes/negotiates timelines for completion of study related statistical activities.
- Ensures the study timelines are met.
- Generates SAP for pooling studies for regulatory submissions and executes them, ensuring that accurate statistical methods are used in the analyses.
- Assists with writing and reviewing statistical sections of integrated summary reports.
- Plans and coordinates interim analyses, as needed.

SKILLS

Must have a Ph.D. in Statistics or a related field with at least 5 years of pharmaceutical research experience. Excellent knowledge of statistical methodology and a working knowledge of computer systems required. Strong knowledge in the SAS statistical analysis system is required. Knowledge of other statistical analysis systems is a plus. Ability to explain statistical information to non-statisticians is critical for success in this role. Knowledge of regulatory requirements governing clinical research needed.
As a senior-level statistician, the consultant is expected to be able to work independently with minimum supervision and manage more complex projects.

Synectics is an Equal Opportunity Employer.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Synectics