CK Group are recruiting for a Statistical Programmer to join a company in the Pharmaceutical industry, working remotely on a contract basis initially for 6 months. The role has been determined as inside IR35 and contracting options are Umbrella company (up to £55.47 per hour) or PAYE via CK (£41.11 per hour). Candidate can be based anywhere in Europe remotely.
Statistical Programmer Role:
Responsibilities may include to:
- Serve as a program or study-level programmer in a defined development program for a client mission.
- Support the programming and analysis of a clinical study within current or future client compounds or across multiple compounds/areas of research.
- Serve as a lead developer of new technologies, such as innovative visualization techniques or other non-traditional pharmaceutical programming.
- Coordinate and provide input for assigned project and study teams on timelines and work product required to deliver high quality statistical programming services in close collaboration with CROs.
- May program, validate, maintain, and document statistical analysis programs for asset development on the basis of the SAP and of other documents (Protocol, CRF, DMM, ISAP, DAP and ASD) following company standard operating procedures and working documents.
- Where applicable, develop innovative programming methodologies (i.e. interactive visualization, dashboards, etc.) to facilitate easier interpretation by customer base.
- Ensure that submission and study datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within client.
- Ensure that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following client procedures and standards.
- Develop specification documentation for datasets (SDTM and ADaM), pooled datasets, tables, figures, listings, and associated metadata.
- Mentor and train other statistical programmers as needed.
- Ensure compliance with the 21-CFR Part 11 regulations in terms of validation of SAS programs used for the purpose of statistical reporting of clinical studies.
- Contribute to and manage statistical programming timelines and commitments to timelines for the study and/or project.
To be successful in this role you should have advanced experience for the statistical programming support for the life cycle of a development compound (from phase I/II through phase IV and post approval activities).
Preference will be given to:
- 3-5 years+ (with Master?s degree) to 5-7 years+ (with Bachelor?s degree) years experience in statistical programming within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) with proven successful track record in pharmaceutical development.
- Excellent understanding and profound knowledge of statistical programming aspects required for regulatory submissions.
For more information or to apply for this Statistical Programmer position, please contact CK Group, quoting job ref 50669.
It is essential that applicants hold entitlement to work in the country where the services will be delivered.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Stephen Lord
- Phone: 01246 457722
- Reference: 50669
Website: CK Group
- Posted: 19th May 2021
- Expires: 16th June 2021