Stephanie Maccioni is recruiting for a Senior Statistician to join a join a small, but growing Biometrics team - not just to deliver Statistics for this exciting portfolio of studies, but to help shape and influence how a Pharmaceutical Company drives excellence for the future. This role can be site or home based with regular visits to their site in Cambridge on a permanent basis.
The Senior Statistician is a member of the clinical team and is responsible for statistical input, including SAS programming, to clinical studies. The Senior Statistician must ensure that activities and processes performed are conducted according to company requirements. This position works closely with other team members.
Principal responsibilities will include to:
- Act as a statistical contact
- Interact with Data Management personnel as necessary to ensure that the data are in usable format; perform statistical diagnostics prior to database locking
- Prepare and coordinate for blinded data review meetings prior to database lock
- Perform ad hoc review of data and analyses following unblinding, as required
- Ensure that appropriate programs are developed for reporting clinical studies
- Perform statistical quality control review and program validation for studies
- Interact with report writers in the production of clinical study reports and other documents containing statistical information. Review draft documents
- Provide statistical input into clinical trial protocols
- Input into the development of departmental processes, including standard working practices and operating procedures
- Work and ensure adherence to CDISC standards for applicable clinical trial reporting
- Respond to regulatory questions regarding submissions
- Act as a deputy for the Head of Biometrics where experience allows
- Can sign on behalf of the Head of Biometrics where experience allows
- Carries out their work in a way that will not adversely affect their own, or others', health, safety and security or the environment and reports any shortcomings
- Masters degree in Statistics or a subject with a major statistical component with previous relevant experience (production of statistical analysis plans and statistical reporting/generating TFLs are essential for this role)
- Good knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines
- Proficient in the use of computers and especially the SAS system
- Ability to perform and interpret statistical analyses of clinical data
- Have a good understanding of clinical data, including data quality issues
- Able to work in a fast-paced, team-oriented environment
- Possess excellent interpersonal and communication skills (written and verbal)
- Strong attention to detail with a view to bringing studies to a quality conclusion
- Flexible, positive, creative thinker, good communicator
- Able to work without close supervision
- Well-developed time management skills
- Previous management/leadership experience is desirable
Full job description available upon request.
For more information or to apply for this position, please contact Stephanie Maccioni on 01438 768713 or email firstname.lastname@example.org. Alternatively please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and 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 46951 in all correspondence.