Biostatistician Ii

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. **Position overview**: ICON's Global Biostatistics Biotech & Small to Mid-Pharma team continues to grow, and we are looking for experienced Biostatisticians to join this successful and evolving group The Biostatistics team are consistently focussed on identifying and retaining industry leading talent - we would like to continue to hire the best of the best and we will ensure that you are developed, empowered and proactively supported in your role. From executive levels down to our first line managers we actively encourage a people first culture where work life balance is valued, "get to know each other" virtual coffee sessions are the norm, conference attendance is encouraged and staff recognition programs are valued and appreciated. Using an enabling and engaging management style we are able to ensure that our Biostatisticians have time to benefit from the best in class training, development and mentoring initiatives we have in place at ICON alongside ensuring that each individual maintains and maximises their professional memberships and networks. Key differentiating features of our team: - We work in an account or therapeutically aligned (TA) structure which provides opportunities to either specialise in a certain TA (e.g. oncology), work with specific clients, work only on data monitoring committee reporting, or a combination of these. - Supporting our team we have a Biostatistical Consultancy Services team who can provide internal expertise and support, as well as provide internal job growth opportunities. - We have a dedicated Data Monitoring Committee Unit, which includes DMC specialists, DMC Project Managers, and unblinded programmers and biostatisticians. - A Talent Advisory Group to provide Biostatistics and Statistical Programming a path for technical and practical expertise to ensure availability of a highly-skilled and motivated talent pool to successfully meet individual, functional, and customer goals - Multiple talent development and training programs including; - Oncology Academy - Graduate Biostatistician & (advanced) Programmer Academies - Monthly Biostatistician & Programmer Forums - CDISC training Your role as a Biostatistician at ICON will involve the following: - Providing statistical oversight across clinical trials in all phases and in a wide variety of therapeutic areas. - Designing, planning and executing Biostatistical components of clinical trials including study design, cross functional risk assessment, writing Statistical Analysis Plans (SAP), inferential analysis programming, study reporting / submission. - Functional lead responsibility for the statistics and programming portion of the study including accountability for timelines, budget and resourcing of the study - Mentoring junior Biostatisticians through our structured graduate training programme We are committed to optimising the potential of each individual on the team and will work with you to evolve your role to ensure your maximum potential is achieved **Responsibilities**: - Serves as the lead biostatistician on programs of studies or submissions, or on simple to complex individual studies. - Serves as an independent reporting statistician on data monitoring committees. - Develops statistical analysis plans and reporting specifications for simple to complex clinical studies. - Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies. - Performs senior review of TFLs and statistical analysis plans. - Provides significant input in the development and review of CRFs, edit specifications, and critical variable lists. - Performs lead review of TFLs and derived datasets for clinical studies. - Contributes to clinical study protocols and clinical study reports. - Reviews simple to complex randomization specifications and dummy randomization schemes. - Trains and mentors new or junior statisticians on statistical methods and ICON procedures. - Provides statistical training at monthly seminars. - Participates in bid defense meetings. - Role can be fully remote anywhere in the US or Canada **Qualifications**: - Master's degree in statistics or biostatistics required. - Minimum of 3-5 years of biostatistical experience desired. - Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures, and good progra