At a Glance
- Tasks: Lead statistical analysis for clinical trials, ensuring quality and timely deliverables.
- Company: Join Phastar, a top global biometric CRO known for its quality and employee satisfaction.
- Benefits: Enjoy flexible working hours, structured training, and a supportive work environment.
- Why this job: Make an impact in clinical research while helping the planet with our tree-planting initiative.
- Qualifications: PhD or MSc in Biostatistics; experience in the pharmaceutical industry is a plus.
- Other info: Remote work available; we value diversity and equal opportunities.
The predicted salary is between 43200 - 72000 ÂŁ per year.
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
- Program and validate primary efficacy datasets
- Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation
- Liaise with clients to propose alternatives or additional analyses if needed
- Develop and validate macros for statistical analyses and figures
- Perform stage 3 QC
- Create, validate and QC efficacy dataset specifications for single studies, ISS/ISEs, etc
- Write SCS/SCE or ISS/ISE SAPs under supervision; DSMB SAPs and Charters under supervision
- Perform QC of SAP text and develop standard SAP text and templates to be used within the company
- Quality Control of TLF shells
- Lead review process of shells with medical writing and other stakeholders
- Create or adjust project level, therapeutic area level or standard templates
- Write statistical section of protocol for simple study design
- Conduct independent critical protocol review
- Manage day-to-day workload to ensure project deliverables are met
- Awareness of CDISC standards
- Consult with clinical scientists to decide on best approach for sample size calculation, and execution
- Perform QC of sample size calculations
- Perform more complex simulations
- Create more complex randomisation schemes and QC of dummy randomisation schemes
- Work as unblinded lead reporting statistician producing unblinded outputs
- Distribute and communicate interim analyses to appropriate stakeholders
- Coordinate and lead clinical interpretation meetings
- Complete clinical trial transparency forms
- Write CSR text as required
- Review of clinical study reports for accuracy
- Archive study documentation following instructions in supplied SOPs
- 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
- Implement Good Clinical Practice and adhere to regulatory requirements at all times
- Lead a team for furthering statistical research
- Develop and deliver company-wide training
- Act as a Study Project Lead, managing resources and timelines
- Work independently as a statistical lead on behalf of other companies
- Attend and input to company resourcing meetings
- Create, review and update processes and SOPs
- 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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Senior Biostatistician employer: PHASTAR
Contact Detail:
PHASTAR Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Biostatistician
✨Tip Number 1
Make sure to highlight your experience with clinical trials and biostatistics in your conversations. Phastar values expertise in these areas, so be prepared to discuss specific projects you've worked on and the impact of your contributions.
✨Tip Number 2
Familiarize yourself with 'The Phastar Discipline' and their approach to data analysis. Being able to speak knowledgeably about their methodologies will show that you are genuinely interested in their work and align with their quality standards.
✨Tip Number 3
Network with current or former employees of Phastar if possible. They can provide insights into the company culture and what it takes to succeed there, which can be invaluable during interviews.
✨Tip Number 4
Prepare to discuss your teamwork and leadership experiences. Since the role involves leading teams and collaborating with various stakeholders, showcasing your ability to work well with others will be crucial.
We think you need these skills to ace Senior Biostatistician
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Senior Biostatistician position. Tailor your application to highlight relevant experiences and skills that align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in biostatistics, particularly within the pharmaceutical industry. Mention specific projects or roles where you demonstrated your ability to produce and validate complex outputs, as well as your familiarity with GCP and regulatory requirements.
Showcase Your Technical Skills: Detail your technical expertise in programming and statistical analysis. Include any relevant software or tools you are proficient in, such as SAS or R, and provide examples of how you've used these skills in previous roles.
Express Your Passion for Quality: Phastar values quality and technical expertise. In your application, convey your commitment to maintaining high standards in your work. Share examples of how you prioritize quality in your projects and how you contribute to a positive team environment.
How to prepare for a job interview at PHASTAR
✨Showcase Your Technical Expertise
As a Senior Biostatistician, it's crucial to demonstrate your deep understanding of biostatistics and clinical trial methodologies. Be prepared to discuss your previous experiences in programming, validating datasets, and your familiarity with GCP and regulatory requirements.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past projects where you had to manage timelines, lead teams, or handle complex statistical analyses, and be ready to explain your thought process and outcomes.
✨Emphasize Team Collaboration
Phastar values teamwork, so highlight your ability to work collaboratively with cross-functional teams. Share examples of how you've supported junior statisticians or liaised with clients to propose alternative analyses, showcasing your leadership and communication skills.
✨Align with Phastar's Values
Research Phastar's unique approach, 'The Phastar Discipline', and their commitment to quality and environmental initiatives. During the interview, express your passion for quality and how you can contribute to their mission, including any relevant ESG initiatives you support.