Veristat has joined forces with SQN! Together we are looking to expand within the UK.
We have built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.
Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. You can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our team!
- Develop, maintain and validate SAS programs for the production of analysis datasets, tables, figures, and statistical analyses for inclusion in clinical study reports, according to specifications, within agreed timelines and budget, in accordance with Statutory Instrument 2004 No. 1031 The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, as well as ICH guidelines, to high quality standards.
- Prepare and review/validate statistical analysis plans, including shells for tables, figures and listings. Develop and review/validate specifications for analysis datasets.
- Provide input into study protocols, especially statistical section and sample size calculations; review and QC of study protocols. Participate in consultations with clients about study design.
- Consult with sponsor on most appropriate randomisation scheme; agree randomisation schedule with sponsor; QC of randomisation schedule.
- Ensure study file is complete; initiate archiving activities.
- Preparation and QC of Biometric reports; input into Clinical Study Reports (incl. QC).
- Coordinate the programming and statistical activities of assigned projects; monitor resource utilisation versus budget; track project milestones; provide updates to project manager and line manager.
- Ensure CRF is reviewed from a statistical perspective before finalisation.
Project management & Client Coordination
- Act as a project manager on projects conducted entirely in the statistics function.
- Provide point of contact with the client; establish and maintain communication channels.
- Build knowledge of client's statistical requirements; ensure consistent application of standards across project teams; realise synergies and efficiency gains across projects.
- Attend relevant team meetings, including hand-over, kick-off meeting, and regular team meetings; ensure statistical aspects are discussed when necessary.
- Provide input into quotations, and monitor resource utilisation versus budget; identify out-of-scope work; provide project updates to project manager and to financial director.
- Delegate and prioritise programming and validation activities within the statistics project team; work with line managers to ensure adequate cover for these tasks; identify challenges early on.
- Set up and maintain project resourcing forecasts, ensure projects appropriately resourced and deliver projects to the required quality, budget and timelines.
- Keep training record up to date.
- Prepare and maintain training material; identify needs for new or updated training material.
- Present training material at departmental meetings.
- Act as a mentor to new or junior members of staff.
- Contribute to quotations on request; review the assumptions underlying the statistical cost.
- Contribute to preparation of bid defence meetings; attend bid defence meetings as required.
- Contribute to regular review of process documents; coordinate reviews; lead and coordinate the production of new documents, ensuring appropriate input is received.
- Contribute to, and lead, process improvement initiatives, both in statistics and across departments.
- Participate in statistical consulting, provide support to Consultant Statistician; identify areas where consultation is needed.
- Represent Syne qua non at external meetings with clients, as well as conferences; participate in the preparation and delivery of presentations.
- Develop and maintain a broad knowledge of statistical techniques and at least a basic knowledge across several therapeutic areas
- Remain conversant with SQN SOPs, customer SOPs (as required) and participate in SOP updates;
- Develop and maintain working familiarity with SQN project tracking, resource tracking;
- Ensure time is recorded according to project-specific requirements and general SQN guidelines;
- Provide back-up support to other staff within the statistics department to provide coverage during annual leave and absences;
- Maintains an overall understanding of all relevant legislation, regulations and guidelines;
- Keep abreast of regulatory and scientific developments by, for example, reading relevant publications, attending courses and through membership of relevant professional associations;
- Keep up-to-date with current industry practices, regulatory requirements and industry news;
- Participate in the training and orientation of new staff;
- Attend all training as required by SQN.
- Further responsibilities may be delegated by management, as appropriate.