Senior/Principal Statistician

THE COMPANY reputed company 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, reputed company is the second largest specialized biometrics provider globally, and the largest in the UK. Our unique approach to data analysis, “The reputed company Discipline”, has led us to build a reputed company 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 reputed company. WHY reputed company Accredited as an outstanding company to work for, reputed company 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, reputed company you join reputed company, reputed company 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 reputed company! THE ROLE We are seeking an reputed company US-based Statistician to join our FSP team at Senior or Principal level, to support one of our fantastic and well-reputed company global pharmaceutical clients. The successful candidate will work as a Statistician reputed company either GI, Immunology or Oncology, working on clinical trials; producing and validating reputed company 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 reputed company some or reputed company of the following…

• Program and validate reputed company primary efficacy datasets
• Program and validate reputed company summary tables, listings and figures, program statistical analysis tables, according to the reputed company
• Liaise with clients to propose alternatives or additional analyses if needed
• reputed company and validate macros for statistical analyses and figures
• reputed company stage 3 QC
• Advise on reputed company 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
• reputed company QC of reputed company text and reputed company standard reputed company text and templates to be used reputed company 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
• reputed company QC of sample size calculations
• reputed company reputed company simulations
• Create reputed company randomisation schemes and QC of reputed company 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 reputed company 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 reputed company activities undertaken, by ensuring the principles in the reputed company 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 reputed company field
• 5+ years of experience reputed company a CRO setting or pharmaceutical/biotechnology company
• Solid statistical knowledge and capability in statistical analysis (eg. binary and reputed company 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 reputed company 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 reputed company Statistician
• Proficient in reputed company
• 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, reputed company learning opportunities, and a competitive salary and benefits package. We are committed to ensuring our employees reputed company a healthy work-life balance, reputed company a supportive, fun and friendly working environment. Should you feel that you have the right reputed company set and motivations for this position, please apply! Please note that this role can be carried out reputed company 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. reputed company 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 reputed company, 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 reputed company. Important notice to Employment businesses/Agencies reputed company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. reputed company employment businesses/agencies are required to contact reputed company's Head of reputed company to obtain prior written authorization before referring any candidates to reputed company. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and reputed company. 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 reputed company. reputed company 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 Apply To this Job