Contract Statistician

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 We are seeking an experienced Statistician to join our FSP team to support one of our global pharmaceutical clients. The successful candidate will work as a Consultant Statistician on either Rare Disease or Neuroscience clinical trials. The candidate will be involved in the cross functional delivery of clinical development statistical designs, have oversight of efficiency and design choices, sit on strategic cross functional teams with input to development plans of clinical development teams, have regulatory experience including understanding of PMDA/EMA landscape (e.g. production of briefing documents), be involved in Governance meetings with the client including chairing cross functional meetings for determining timelines and deliveries, as well as having general oversight and driving the clinical development plan deliveries including study level. The candidate should have knowledge of biomarkers and PK/PD modelling experience. Although PK/PD is handled by a different vendor, the successful candidate should have knowledge of this area to be able to make informed decisions of modelling/simulations. This position will be a 6-month contract and can be fully remote or office-based/hybrid (depending on the successful candidate's location), and can also allow travel to Denmark once a month if the candidate is able to do so. Responsibilities Employees may be required to perform some or all of the following: • Advise on complex analyses and endpoints; ensure consistency across clinical trial program • Ensure clients and/ or other external bodies are consistent • Create, validate and QC of efficacy dataset specifications for single studies, ISS/ISEs, etc • Write ISS/ISE SAPs; DSMB SAPs and Charters • Write project level or therapeutic area level documentation • Peer review of SAPs if complex statistical issues • Ensure client and/ or other external bodies are consistent • Identify the need and provide review of new standards and project level shells ensuring consistency across clinical trial programs • Conduct independent critical protocol review • Provide statistical consultancy for clinical trial program development • Defend clinical study designs with health authorities • Consult with clinical scientists to decide on best approach for sample size calculation, and execution • Input/ oversight into complex sample size calculations • Create more complex randomisation schemes and QC of more complex randomisation schemes • Work as unblinded DSMB statistician involved with liaising with committee members • Distribute and communicate interim analyses to appropriate stakeholders • Attend meetings as the independent statistician on the committee • Liaise with health authorities regarding unblinded data • Identify need to adjust current or future clinical trial protocols based on outcome • Generation and defence of project level regulatory documentation • 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 • 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 • Initiate projects/ ideas for furthering statistical research • Teach consultancy or project leadership related skills internally and externally • Identify internal non-technical training needs • Lead regulatory strategies • Work as oversight statistician for regulatory bundle • Work independently as a statistical lead on behalf of other companies • Attend and input to company resourcing meetings • Identify and implement new processes to ensure quality • Recognise opportunities to influence industry standards and facilitate changes, influence regulatory bodies to support clinical project plans Qualifications • Educated to PhD or MSc in Biostatistics, statistics or a related discipline • Experience within the pharmaceutical industry to have a good awareness of clinical trial issues, design, and implementation • 5+ years experience within clinical development • Familiarity with GCP and regulatory requirements • Experience of writing SAPs, protocols & regulatory submissions • Rare disease experience is advantageous • Excellent communication and relationship building skills 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, Ireland, Spain, Germany, France, Denmark or Poland 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. Important notice to Employment businesses/Agencies Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.