job details for:
Clinical Research - Principal Statistician Jobs - Cambridgeshire

Clinical Research - Principal Statistician Jobs - Cambridgeshire (Job Ref: WR/JOBS/19123-7088)

Job Description :

Job Summary

Flame Pharma Clinical Research - Principal Statistician Job - Cambridgeshire:

An opportunity for a skilled statistician to work with one of the largest companies in the pharmaceutical sector has arisen for a talented and skilled Principal Statistician.

If you are looking for a challenge and to accelerate your career within Statistics by working on multiple statistician projects for world leading clients, then this position is for you.

Job Title

Principal Statistician

Background

Due to expansion, our client are looking to recruit a Principal Statistician to provide expert statistical, process and regulatory knowledge to the department. Perform project management function within the Biostatistics department.

Key Responsibilities

• Be familiar with and follow the departmental and company standard operating procedures (SOPs) and working practices (WPs)
• Provide expertise in the development and delivery of training material, and the implementation of departmental procedures for the Biostatistics team
• Serve as a lead statistician on multiple projects. · Ensure projects are well documented consistent with company SOPs and working practices
• Lead a project team for multiple protocols. This involves conducting team meetings, maintaining project timelines, assessing resource need, providing resources, and budget management
• Ensure that SOPs are being followed and that appropriate project documentation is ongoing
• Project Manage Biostatistics only projects
• Allocate and co-ordinate resources within the team to achieve timelines, time management of own and team’s time spent on projects
• Provide statistical consultative service to sponsors
• Interact with the sponsor on statistical aspects of the project and present at meetings as required
• Provide the Project Manager, Biostatistics department and company management with timely, accurate status and resourcing reports
• Produce sample size calculations. Provide input into study design and statistical considerations, during protocol development
• Review protocols for completeness, appropriateness of clinical design and sound statistical analysis
• Contribute to writing appropriate protocol sections
• Lead the development and review of statistical analysis plans, including table, listing and graph specifications
• Specify the general structure of the analysis database, oversee its development, and ensure completeness for use in all programming
• Organise the production of statistical analyses and statistical appendices, with appropriate documentation
• Ensure that appropriate validation for statistical analyses and statistical appendices is implemented
• Oversee the preparation and review of Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy and other documents, as required
• Contribute statistical methods section for Integrated Clinical Statistical Reports
• Review Integrated Clinical Statistical Reports
• Oversee the Quality Review of the statistical reporting of selected projects.
• Provide Senior Review on selected projects
• Provide expert knowledge within the department on statistical and regulatory issues, mentoring members of the department and providing project guidance and statistical advice
• Provide expert knowledge and experience of complex trials design across different therapeutic areas
• Provide input to management as to hiring recommendations, department policies, and resourcing requirements
• Contribute to process improvement and departmental initiatives
• Contribute to the identification and development of department documents or policies, input into SOP/WPD development and revision, and training of new employees
• Act as the representative of the department to other divisions
• Act as a representative of the department to the larger statistical Pharmaceutical/CRO environment
• Assist in bidding and business development activities, as required. Providing statistical expertise within the company

Qualifications & Experience

• Advanced degree (MSc or PhD) in statistics, or related field
• CStat status required
• Expert knowledge of the statistical principles underlying clinical trials
• Expert statistical skills
• Expert knowledge of the regulatory issues associated with the reporting of clinical data in the submission process
• Expert consultative skills
• SAS® programming skills and familiarity of other statistical packages (e.g. StatXact, Nquery) and understanding of database structures.
• Good organisational skills across multiple projects, managing own and team work loads
• The ability to adapt and adjust to changing priorities
• Excellent written and verbal communication skills
• Ability to work in a multi-disciplinary team setting
• Demonstrated initiative, motivation and problem solving skills
• Positive attitude and the ability to organise a team and work well with others 
• Evidence of mentoring skills as shown by leadership of multiple projects and team members
• Evidence of providing expert statistical input in previous positions and presenting at statistical conferences would be an advantage

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary from £30,000.

Key Words

Principal Statistician, Statistician, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

There are current vacancies in Cambridge, Bellshill and Winchester.

For more information and to apply for this position, please contact Flame Pharma on 0800 085 0858.