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EST 1985
Serving classified ads since 1985.
Serving classified ads since 1985.
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Associate Director Biostatistics- Global Pharma- Home Based

Description

Location England

Type Permanent

The Associate Director(s) of Biostatistics will be integral roles in this push to maintain a balance of workload and leadership. Lead teams of statisticians and programmers in respective therapeutic portfolios and define guidelines of excellence for standards of end-to end biostatistical projects.

Responsibilities:

  • Direct a team of internal biostatistics and statistical programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development. Manage duties and responsibilities of team members.
  • Work collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
  • Perform project statistician duties; including attending of study team seminars, authoring SAPs, reviewing CRFs, design of phase 1-3 and PK studies, review of protocols/amendments, performing exploratory data analyses, and presenting analyses.
  • Ensure high quality and timeliness of deliverables from the Biostatistics department. Oversee and substantiate high quality level of the Biostatistics expert review process
  • Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports, including clinical trial results, exploratory and meta-analysis results, modeling and simulation in support of various activities, support for publications, scientific presentations, and support to product defense.
  • Acts as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel (protocols, CSRs, regulatory documents, and manuscripts), and serves as an internal consultant as assigned on broad statistical issues that impact on the pharmaceutical/Biotechnology industry.
  • Conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods, and develops new methods
  • Determine the functions most critical to company success and to support priorities within functional area.

Qualifications:

  • A PhD in Statistics/Biostatistics and at least 7 years of relevant pharmaceutical experience or a MSc in Statistics/Biostatistics and at least 10 years of relevant pharmaceutical experience
  • Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
  • Knowledge of CDISC requirements for SDTM and ADaM
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