I am a Statistician who hold a MSc in Statistics, working as a statistician on multiple clinical trials and I have passion for data and information. Over ten years’ experience in data analysis, interpretation and presentation. I am organised with a keen eye for detail, I always ensure that the work is completed on time and to high standard. I have experience in statistical aspects of clinical research, including statistical analyses, creation, and quality control of SDTM/ADaM datasets and tables, figures and listings using SAS, regulatory requirements to support electronic submissions. Experienced in clinical study phases I-III. Experienced in the following therapeutic areas; antiviral, hypertension, oncology, respiratory and vaccine. Strong focus on delivering to time and quality expectations with excellent leadership and communication skills and willingness to support and mentor others. Ability to work both within a team environment and independently, as required.
· Act as the Statistician on programs of studies, submissions, or on non-complex individual studies.
· Ensures quality and timely delivery of all statistical aspects of study.
· Program and validate 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.
· Programming inferential analysis using SAS, including appropriate sensitivity analyses and model checking.
· Write study level SAP text copying from a similar study or amending a standard template .
· Review statistical analysis plans and reporting specifications (mock shells).
· Create all study level shells, ensuring templates and standards are adhered to.
· Performs reviews of datasets, tables, listings and figures and of statistical analysis plans.
· Active contributor to provision of ongoing statistical training and shared learning
· Awareness of CDISC standards.
· Provide statistical consultancy and statistical advice.
· Cross-check results in CSR vs final outputs.
· Perform simple sample size calculations with supervision.
· Manage day-to-day workload to ensure project deliverables are met.
· Working alongside cross-functional teams to ensure that statistical aspects are in line with expectations.
· Archive own study documentation following instructions in supplied SOPs.
· Experienced oncology, psoriasis, sepsis and rheumatology trials.
· 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.
Athletics, Volleyball and Tennis
Enjoying fishing and reading books
Technical Skills: