Biostatistician II

Salary: £100000 to £999999
Contact name: Matthew Vesty

Contact email: matthew.vesty@medella.life
Job ref: 313
Published: 14 days ago

Biostatistician II

 

Responsibilities

 

The Biostatistician II is responsible for having a working knowledge of all related processes with the ability to independently lead a study, support analysis, and provide high?quality documents to support sponsors' research programs

 

Tasks Performed

 

  • Generate randomization schedules using SAS or randomization specific software.
  • Develop and quality control (QC) review statistical analysis for simple to complex studies.
  • Develop or assist in developing the Statistical Analysis Plans (SAPs) and related table, figure, and listing (TFL) shells for studies of simple to moderate complexity.
  • Development of tables of summary statistics and graphics for clinical aspects of clinical trials.
  • Assist in answering deficiency letters from regulatory agencies, as required.
  • Utilize SAS to validate statistician programs and results.
  • Perform QC review of analyses and documents prepared by other team members for completeness, accuracy, consistency, and structure.
  • Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.
  • May represent Biostatistics in client and inter-departmental meetings.
  • Follow department and company standard operating procedures (SOPs), forms, templates and policies.
  • Act as Lead Biostatistician for simple to complex studies and be the central point of contact for the assigned Biostatistics team, extended internal project team and the client .
  • Provide input for Biostatistics portion of project timelines.
  • Review of protocols for simple to complex studies.
  • Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines.
  • Maintain familiarity with client and internal team expectations and produce analyses and documents consistent with these.
  • Have awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], FDA, European Medicines Agency [EMA], etc) as well as ICH and GCP procedures.
  • May participate or lead departmental or interdepartmental quality improvement initiatives.
  • Maintain and participate in the objectives of the department.
  • Other duties as assigned.

 

Qualifications

 

Bachelor's Degree or higher in Statistics or related field.

 

 

Skills:

 

  • Excellent verbal and written communication skills.
  • Professional attitude and strong interpersonal skills.
  • Ability to work well with a multi-disciplinary team of professionals.
  • Client-focused approach to work.
  • Flexible attitude with respect to work assignments and new learning.
  • Ability to prioritize workload.
  • Superior attention to detail.
  • Understanding of clinical research project life cycle and applicable regulatory guidelines.
  • Good computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to information technology (IT) systems as needed.
  • Moderate SAS programming proficiency.