Senior/Principal 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 are 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 is 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, but you will also be helping to save the planet! THE ROLE We are seeking an experienced US-based Statistician to join our FSP team at Senior or Principal level, to support one of our fantastic and well-known global pharmaceutical clients. The successful candidate will work as a Statistician within either GI, Immunology or Oncology, working on clinical trials; producing and validating complex outputs to excellent quality whilst adhering to deliverable timelines. We are looking for someone who is bright, adaptable, agile – an individual that possesses excellent communication and relationship building skills. This position is full-time and fully remote. RESPONSIBILITIES: Employees will be required to perform some or all of the following… • Program and validate complex primary efficacy datasets • Program and validate complex summary tables, listings and figures, program statistical analysis tables, according to the SAP • Liaise with clients to propose alternatives or additional analyses if needed • Develop and validate macros for statistical analyses and figures • Perform stage 3 QC • Advise on complex analyses and endpoints; ensure consistency across clinical trial program • 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 • Perform QC of SAP text and develop standard SAP text and templates to be used within the company • Identify the need and provide review of new standards and project level shells ensuring consistency across clinical trial programs • Write statistical section of protocol for any study • Provide statistical consultancy at study design stage or during program development • Conduct independent critical protocol review • Consult with clinical scientists to decide on best approach for sample size calculation, and execution • Perform QC of sample size calculations • Perform complex simulations • Create complex randomisation schemes and QC of 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 DSMB committee • Coordinate and lead clinical interpretation meetings • Complete clinical trial transparency forms and input into project level regulatory documentation • Senior review of CSR • Archive study documentation following instructions in supplied SOPs • Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed • Create, review and update processes and SOPs, identify areas where new processes are required SKILLS AND EXPERIENCE REQUIRED: • Educated to PhD or MSc in Biostatistics/Statistics or a closely related field • 5+ years of experience within a CRO setting or pharmaceutical/biotechnology company • Solid statistical knowledge and capability in statistical analysis (eg. binary and continuous data analysis, missing data handling, etc.) • Extensive CDISC experience (SDTMs and ADaMs) • Experience of writing SAPs, protocols • Cross-functional experience • Experience in novel study design, Bayesian statistics, or complex statistical analysis/modeling/simulations is advantageous, but not essential • Previous GI, Immunology and/or Oncology experience is advantageous, but not essential • Experience in outcomes is advantageous, but not essential • Experience in late-phase (phase 2 and phase 3 studies) and submission work is advantageous, but not essential • Previous experience working as a Lead Statistician • Proficient in SAS • R software experience is advantageous, but not essential • Ability to work independently and collaboratively in a fast-paced environment APPLY NOW With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialised 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 are 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 this role can be carried out anywhere in the US, as it will be fully remote - however the preference would be for the successful candidate to be located on the East Coast. 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. Apply tot his job