Associate Principal Biostatistician

Company: Premier Research
Location: Quincy
Posted on: January 10, 2021

Job Description:

Wish you were here? Recognised recently as a Top CRO by Life Science Leader, Premier Research is a medium sized, full service, global CRO with circa 1,500 employees worldwide, perfectly positioned to be big enough to help, yet small enough to care. We have an aspiring and empowering culture and strive to work globally as #oneteam. Premier helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as Oncology, Neurology, Paediatrics, Rare Diseases and Medical Devices, supporting the needs of smaller Pharmaceutical organisations and Biotech companies. There is real opportunity to work across multiple clients on a variety of unique and interesting studies including integrated analyses and regulatory submissions. Continued growth means we are excited to have the chance to add a Senior / Lead Biostatistician to our Biostatistics team. We can consider office, home based or a mix of the two across many locations. This is a great opportunity to advance your skills (such as lead studies, IND submissions and high-level consulting work) and grow with a company who recognizes you as an individual in an aspiring, caring and empowering culture. Interested to join a forward thinking, family feel company which offers real opportunity to add value and help improve patient lives whilst having fun? And at Premier Research, its not all work, work, work - across our offices, there are always numerous social & extra-curricular events to get involved in should you so wish, whether it be lunch-and-learns, summer picnics, charity fund raising events, language lessons, or fun contests! If we hear from you, youll hear from us! As a Senior level Biostatistician, youll have the opportunity to represent Premier Research as our primary contact with our sponsors, applying knowledge of statistics to independently provide statistical consulting, assist with study design and protocol development, and performs statistical analysis of clinical trials. Youll review project related documents, prepare statistical analysis plans (SAPs) and statistical reports. You will also develop analysis data specifications, create analysis datasets, Tables, Listings and Graphs (TLG) of clinical trial data using SAS. In this role, youll perform quality control of TLGs and derived data sets created by others, as well as develop and validate SAS programs, macros, and utility tools. Youll also have the unique opportunity to work on NDA submissions-to engage with studies at the program levelpreparing Clinical Summaries of Safety (ISS) and Efficacy (ISE). What youll be doing: Independently utilize your respected expertise to provide statistical consulting Prepare statistical sections of protocols, performing sample size and power calculation for studies, and create randomization schedule per study design and relevant specifications Review protocols, case report forms (CRFs), data management plans, data specifications and other related study documents Develop statistical analysis plans (SAP) in accordance with the protocols and SAS programs to create statistical models and complete statistical analyses Support integrated summaries of safety and efficacy (ISS and ISE) for regulatory submissions Independently prepare analysis data specifications Develop SAS programs to create derived variables and analysis data sets and computer programs to generate listings, tables, and graphs using SAS Perform quality control of analysis data and TLGs Review and provide input in interpreting analysis result to clinical study report You'll Need this Background to be Considered: Advanced degree (MS or PhD, or equivalent) in statistics or closely related field along with 4-6 years (or 3-5 years for PhD) of direct experience of clinical trials design and regulatory knowledge and analysis with advanced SAS programming experience Proven knowledge of CDISC standards and application of those standards to projects; demonstrated working knowledge of advanced SAS macro development and code generation/management algorithms Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills Detail oriented, well organized with the ability to work on several projects simultaneously Excellent team player, collaborative and maintains a positive, results-orientated work environment Accountable, dependable and demonstrates strong commitment to the role Is customer service focused in approach to work, both internally and externally

Keywords: Premier Research, Quincy , Associate Principal Biostatistician, Other , Quincy, Massachusetts