Senior Biostatistician

Overview

THE COMPANY

Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.

Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

WHY PHASTAR

Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.

What’s more, when you join our team, Phastar will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you’ll also be helping to save the planet!

THE ROLE

Work as a statistician on clinical trials; producing and validating complex outputs to excellent quality whilst adhering to deliverable timelines. Producing and reviewing Statistical Analysis Plans (SAPs), protocols and other pertinent study documentation. Acting as lead statistician within a reporting team environment, being responsible for statistical aspects of reporting out study results. Working as a global lead statistician across multiple studies, overseeing more junior leads and supporting regulatory interactions. Preparing randomisation schedules and acting as the unblinded statistician on reporting teams. Acting as a statistical consultant to pharmaceutical or biotech companies. Excellent team work ethos, and willingness to help others. Potential to have line management responsibilities.

Responsibilities

1. Program and validate primary efficacy datasets
2. Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation
3. Liaise with clients to propose alternatives or additional analyses if needed
4. Develop and validate macros for statistical analyses and figures
5. Perform stage 3 QC
6. Create, validate and QC efficacy dataset specifications for single studies, ISS/ISEs, etc
7. Write SCS/SCE or ISS/ISE SAPs under supervision; DSMB SAPs and Charters under supervision
8. Perform QC of SAP text and develop standard SAP text and templates to be used within the company
9. Quality Control of TLF shells
10. Lead review process of shells with medical writing and other stakeholders
11. Create or adjust project level, therapeutic area level or standard templates
12. Write statistical section of protocol for simple study design
13. Conduct independent critical protocol review
14. Manage day-to-day workload to ensure project deliverables are met
15. Awareness of CDISC standards
16. Consult with clinical scientists to decide on best approach for sample size calculation, and execution
17. Perform QC of sample size calculations
18. Perform more complex simulations
19. Create more complex randomisation schemes and QC of dummy randomisation schemes
20. Work as unblinded lead reporting statistician producing unblinded outputs
21. Distribute and communicate interim analyses to appropriate stakeholders
22. Coordinate and lead clinical interpretation meetings
23. Complete clinical trial transparency forms
24. Write CSR text as required
25. Review of clinical study reports for accuracy
26. Archive study documentation following instructions in supplied SOPs
27. Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own work
28. Implement Good Clinical Practice and adhere to regulatory requirements at all times
29. Lead a team for furthering statistical research
30. Develop and deliver company-wide training
31. Act as a Study Project Lead, managing resources and timelines
32. Work independently as a statistical lead on behalf of other companies
33. Attend and input to company resourcing meetings
34. Create, review and update processes and SOPs
35. Take responsibility for study compliance

Qualifications

• PhD or MSc in Biostatistics or related discipline
• Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation. Familiarity with GCP and regulatory requirements.

APPLY NOW

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.

Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the UK as this role can be carried out remotely.

Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.

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