Senior Statistician - (Southern UK, UK)
Please find below the details of our latest position. This role is a Senior Statistician position based in Southern UK, offering excellent rates and the opportunity to work with a leading Global Pharmaceutical.
The Senior Statistician is responsible for all statistical tasks of individual clinical trials. He/she may take on project level tasks of a Program Statistician, initially under the supervision of a more experienced Statistician/Group Head but with increasing autonomy and accountability.
Major Activities - Be responsible for all statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence e.g.: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase.
- May be assigned to lead a small project or parts (e.g. indication) of a project, initially under the guidance of a more experienced statistician, but with increasing autonomy and accountability.
- Track clinical trial/allocated project activities and milestones.
- Ensure timeliness and adequate quality of all B&SR deliverables for the assigned trials and project tasks.
- Follow processes and adhere to Client and project specific standards as well as Health Authority requirements (SOPs, NIPs, Master Analysis Plan, GCP, and regula-tory guidelines).
- Participate in or lead non-clinical project activities as needed.
- Establish and maintain sound working relationships and effective communication within the Clinical Trial Team/International Clinical Team and the B&SR team.
Key Performance Indicators (Indicate how performance for this role will be measured)- Quality and timeliness of statistical contributions (e.g. design, analysis, interpretation) as assessed by the Clinical Program Leader or Clinical Trial Leader, Program Statistician and/or Biostatistics TA Group Head.
- Quality and timeliness of specifications to the programmer(s) as assessed by the feedback from the programming team.
- Adequate representation of Biostatistics in the Clinical Trial Team/International Clinical Team, and effectiveness of communication as assessed by the Clinical Program Leader or Clinical Trial Leader and Program Statistician.
Impact on the organisation:- Timely preparation and delivery of high quality protocols and analyses for clinical study reports, to be included in regulatory submissions to Health Authorities.
- Efficient production of analyses and reports of clinical trials.
- Acceptability of clinical trial protocols and reports by Health Authorities.
- For parts of projects assigned: Efficient clinical development programs and good quality submissions.
Ideal Background
Education : At least Masters Degree in Statistics (or equivalent degree) with 5 years of experience or PhD with 2-3 years of experience.
Languages: Fluent English (oral or written).
Experience/Professional requirement: - Experience in all tasks of a Trial Statistician.
- Proven knowledge in Statistics and its applica-tions to clinical trials.
- Proven knowledge of drug development and HA guidelines.
- Background medical knowledge, pref-erably in relation to the specific therapeutic area.
- Proven knowledge of statistical software packages.
- Good communication and presentation skills.
- Good team player.
If you would like to discuss this position in detail, or for a confidential consultation on all of our current Biostatistics and Programming opportunities in the UK and Europe, please contact me directly. Details of our current contract and permanent vacancies can also be found at www.hayspharma.com
Chris.Smith [at] hayspharma.com
URL: www.datashaping.com/jobs17142e.shtml
Please mention datashaping.com when applying. Thank you.
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