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Senior Biostatistician

Job Title: Senior Biostatistician
Contract Type: Contract
Location: Greater London, England
Industry:
Salary: Competitive
Start Date: 2019-10-10
Reference: BH-105093
Contact Name: Gregory Robertson
Contact Email: Gregory.Robertson@nesgt.com
Job Published: October 11, 2019 10:39

Job Description

Senior Biostatistician

Role description:

  • Write and/or review statistical analysis plan(s) (SAPs) and table, listings, and graphs (TLG) mock-ups;
  • Review statistical methods of clinical study protocols and clinical study reports (CSRs);
  • Create and validate randomization schedules;
  • Perform statistics-based review of case report forms (CRFs);
  • Perform sample size estimations
  • Provide statistical interpretation of study results;
  • Collaborate with statistical programmers on the development of data sets, tables, listings, and graphs;
  • Quality control of SAS data sets and statistical outputs;
  • Programming of listings/ad hoc analyses;
 

Qualifications:

  • Minimum of MS in Statistics or Biostatics, or other related degree;
  • Minimum of 5 years of clinical trial experience in pharmaceutical and/or biotech company;
  • Advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase VI), including statistical procedures in analysis software, e.g. SAS;
  • Must have worked on statistical analysis plans, study protocols, clinical study reports, and preferably, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports);
  • Advanced knowledge of theoretical and applied statistics;
  • In-depth knowledge of statistical analysis methods and results/data presentation formats of clinical data;
  • Ability to exhibit exemplary experimental techniques, following procedures with the utmost rigor and attention to detail;
  • In-depth knowledge of regulatory regulations and guidances;
  • Proficient in Microsoft Word, Excel, and PowerPoint;
  • Knowledgeable of CDISC requirements for SDTM and ADaM.