Statistician III _India (Remote)
Job details
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 a statistician to work on clinical trials; producing and validating complex outputs to excellent quality whilst adhering to deliverable timelines. Producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Working within a reporting team environment, being responsible for assigned statistical and programming aspects of reporting out study results. Excellent team work ethos, and willingness to help others. This position is remote Responsibilities
- Program, validate and QC datasets including SDTMs and complex datasets, e.g. ADQS, ADLB
- Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation ,
- Create and validate simple dataset specifications for single studies
- Write study level SAP text copying from a similar study or amending a standard template
- Create project level shells, ensuring templates and standards are adhered to
- Simple clinical study under supervision
- Manage day-to-day workload to ensure project deliverables are met
- Awareness of CDISC standards
- Perform sample size calculation for any study
- Perform simple simulations with supervision
- Create actual randomisation schemes
- Work as part of the team producing unblinded outputs
- Cross-check results in CSR vs final outputs
- Archive own 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
- Work in a team for furthering statistical research
- Assist in development of internal training courses
- Being responsible for statistical aspects of deliverables for non-complex deliveries with supervision
- PhD or MSc in Biostatistics or related discipline
- Some knowledge of the pharmaceutical industry with an awareness of clinical trial issues. Familiarity with GCP and regulatory requirements.
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