Principal Statistical Programmer
Ian Marlow at CK Clinical is looking to recruit a Senior Principal Programmer on a permanent basis for a CRO based in Maidenhead.
Our client is a leading global drug development services company who provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for their Phase II-IV team in Maidenhead and are currently seeking to hire a Principal Statistical Programmer to act as the Lead Programmer overseeing technical planning for increasingly complex projects, including global and multiple study projects, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) and electronic submissions.
This is a full time permanent position based in their Maidenhead office or field based within the UK.
Within this position, your duties will include:
- Acting as the Lead Programmer overseeing technical planning for increasingly complex projects including global and multiple study projects, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) and electronic submissions.
- If desired, may supervise less-experienced statistical programmers carrying out line management responsibilities. This would include Performance Management and Development activities, disciplinary procedures and administrative activities.
- Acting as the Biometrics Project Manager for assigned projects.
- Working on complex problems where analysis of situations or data requires an evaluation of intangible variables; development of technical solutions to abstract problems which require the use of ingenuity and creativity.
- Reviewing and interpreting Statistical Analysis Plans and providing comments for assigned projects.
- Ensuring quality of personal work and the work of the programming team when acting as a Biometrics Project Manager and Lead Programmer meeting completions dates with minimal supervision.
- Representing Statistical Programming at internal project team meetings, client meetings and audits.
- Contributing to proposal activities and client presentations providing time and cost estimates for statistical programming activities.
- Performing ongoing review of hours for assigned projects, ensuring all issues are highlighted and resolved as quickly as possible and ensuring all non-contract tasks are identified, tracked and included in change order forms.
- Providing ongoing supervision, advice and consultation to Lead Programmers and programming team to ensure timely and efficient completion of projects.
- Providing feedback to management on the development potential of staff to assist in staff development.
- Performing interviews for selection of potential candidates.
- Ensuring that study documentation is maintained to the standard required according to processes and acceptable for audit.
- Providing input into assessments of resource requirements on regular basis. Providing feedback to management if any action is needed to increase utilization, improve efficiency or amend the resource levels required on a project.
- Encouraging and participating in the ongoing review of the processes used by the statistical Programming group to ensure processes are continually improved.
To be successful in this position, you will need to be educated to BSc level (or equivalent) in a computing, life science, mathematical or statistical subject. Additionally, you will need to demonstrate:
- Considerable experience in provision of programming support for clinical trial management and reporting, or equivalent experience.
- A proven experience of working in a CRO environment.
- Extensive experience and proven skills in the development and review of SAS programs within a clinical trials environment.
- Experience in the preparation and review of Statistical Analysis Plans, study set-up and review of study specific documents, e.g. CRF and data validation guidelines.
- Knowledge of all aspects of clinical trials from initial study set-up to study completion with an excellent understanding of the roles and responsibilities of all related disciplines, e.g. Biostatistics and Clinical Data Management.
For more information or to apply for this position, please contact Ian Marlow on 01438 743 047 or IMarlow@ckclinical.co.uk, or Stephanie Maccioni on 01438 768713 or SMaccioni@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL33628 in all correspondence.