Statistician

Antwerpen  ‐ Onsite
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Keywords

Description

EDUCATION
Master degree in Sciences or equivalent relevant experience within Clinical Research Team player in multidisciplinary teams. Able to plan work to meet deadlines and work under pressure; Good knowledge of English, both spoken and written;

EXPERIENCE
Have a minimum of 7 years of experience as biostatistician in the pharmaceutical industry. Excellent knowledge in fundamental probability, statistical interference, applied statistics and the design of clinical trials;

OTHER QUALIFICATIONS, SKILLS AND ABILITIES
SAS programming skills. Quality minded. Communication skills. Able to translate medical problems into statistical concepts and translate statistical results into medical views

Project Deliverables/Activities will include the following:

  • Contract Employee shall interact with the XXXXX study or project team (XXXX Team), the XXXX Biostatistics discipline (XXXX Biostatistics), and the XXXXX Programming discipline (XXXX Programming), as specified below:
    Collaborate with the XXXXX teams to provide statistical support for randomized clinical trial activities.
  • Collaborate with theXXXXX teams to provide statistical support to study design, including synopsis development, protocol development, sample size and power calculation, and CRF development
  • Provide input to XXXXX biostatistics on the needs of the XXXXX teams
  • Provide input to XXXXX programming on the needs of the XXXXX teams
  • Support the XXXX teams on the selection of and contracting with service providers, including review of proposals, evaluation of service providers, evaluation of candidates for lead statisticians and lead programmers.
  • Provide statistical input to the contracts
  • Provide input to XXXXX team on the development of study timelines
  • Support the clinical study teams on other study start-up and planning activities, including making statistical presentation at the investigators' meetings, and reviewing planning and specification documents from different disciplines and vendors (eg, data management, IVRS, clinical laboratories, ECGs if necessary)
  • Coordinate the study randomization process
  • Provide support on monitoring study progress and provide input on related decision making
  • Review study data for quality and/or patient safety as required
  • Guide CRO statisticians on the development of Statistical Analysis Plans (SAP)Develop SAPs in-house if necessary
  • Review SAPs and coordinate the review by the XXXXX teams
  • Provide guidance and input on the production of tables, figures, and listings (TFLs) as appropriate
  • Review/QC TFLs, using programming when appropriateCoordinate TFL review by XXXX teams
  • Liaison with the XXXXX teams and CROs or the programming teams for timely decisions on data classification (protocol deviations, safety data of special interest, etc.).
  • Monitor CRO work progress and quality, provide input to the XXXXX teams on statistical and programming budget, and out-of-scope (OOS) work
  • Review and provide input to programming deliverables, including data derivation and specification documents, case report tabulations, and meta-data definitions as appropriate
  • Review and provide input to CDISC specification documents and deliverables
  • Support and/or present the study top-line results
  • Support the production of study result summary documents if necessary
  • Review draft clinical study reports (CSR)
  • Review manuscripts, posters, presentations and other publications based on study results
  • Support the discussion and production of ad hoc analyses if necessary
  • Ensure proper documentation and archiving of statistical work in study files
  • Provide statistical support on planning, coordinating, and producing summary clinical data for projects, such as summary of clinical efficacy, summary of clinical safety, safety updates, investigator's brochures, package inserts, and educational materials, if required
  • Ensure statistical timelines are met
  • Ensure quality and scientific/statistical soundness of all deliverables
  • Provide input to XXXX Biostatistics templates, conventions, guidelines, and standards if required
  • Provide statistical input to the XXXXX clinical teams in support of product development strategy development when appropriate.

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Start date
ASAP
Duration
11 months, with a view to extend.
(extension possible)
From
Scope AT Limited
Published at
23.12.2011
Project ID:
286296
Contract type
Freelance
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