Senior Biostatistician

Location 9052 Zwijnaarde, Belgium
Discipline: Biotechnology
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 10645
Published: about 1 month ago

For the expansion of our team, we are looking for a Senior Biostatistician. The senior biostatistician executes diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on managing the statistical activities performed by the biometrics CRO and on guarantying by means of thorough review outstanding statistical quality.

You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the CSR.

YOUR RESPONSIBILITIES:

  • The senior Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:
  • Serves as the responsible biostatistician on Phase I to III clinical trials. The trials can be relatively simple or complex.
  • Contributes to clinical study synopses and protocols.
  • Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
  • Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
  • Provides relevant input in the development and review of CRFs.
  • Performs lead review and sets up internal QC of TFLs.
  • Performs critical review of derived datasets specifications and derived datasets (ADaM).
  • Contributes to clinical study reports.
  • Reviews simple to complex randomization specifications and dummy randomization schemes.
  • Participates in bid defense meetings.
  • Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
  • Contributes to press releases and scientific papers.

YOUR DETAILS:

  • The senior Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:
  • Serves as the responsible biostatistician on Phase I to III clinical trials. The trials can be relatively simple or complex.
  • Contributes to clinical study synopses and protocols.
  • Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
  • Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
  • Provides relevant input in the development and review of CRFs.
  • Performs lead review and sets up internal QC of TFLs.
  • Performs critical review of derived datasets specifications and derived datasets (ADaM).
  • Contributes to clinical study reports.
  • Reviews simple to complex randomization specifications and dummy randomization schemes.
  • Participates in bid defense meetings.
  • Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
  • Contributes to press releases and scientific papers.

ORGANISATION:

We are a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, we are building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development.

OFFER:

  • A competitive salary package with benefits;
  • A work environment in a human-sized, dynamic, rapidly growing biotech company

INTERESTED?

For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.