Senior Consultant/ Principal Consultant Biostatistics (Advanced Analytics)

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Our Advanced Analytics team is expanding and we are recruiting for a Senior Consultant or Principal Consultant Biostatistician. We are looking lead for experienced lead biostatisticians with familiarity with primary observational data studies. Working knowledge of CDISC standards and R will be a plus. Position Overview You will work independently in reviewing protocols, developing SAPs (including mock shells), developing data specifications per CDISC standards, programming and quality control of derived datasets and statistical outputs, production of reports, and providing statistical advice to study teams and clients. Objectives of the role will include: Acting as Lead Biostatistician to interact with the study team and the sponsor Drafting statistical sections of protocols, performing sample size and power calculation for studies, and creating randomization schedules per study design and relevant specifications Reviewing case report forms (CRFs), data management plans, data specifications, and other related study documents Independently developing statistical analysis plans Preparing specifications for CDISC and other analysis datasets Independently developing SAS programs to generate listings, tables and figures as outlined by a statistical analysis plan Performing QC of TLFs, CDISC and other analysis datasets Reviewing study protocols and providing input to statistics section Providing statistical input to Clinical Trial Reports Aiding business development with statistical considerations for new study bids, preparing biostatistics budgets, and attending bid defense meetings Serving as a mentor to junior-level biostatisticians to help develop skills Qualifications Expertise in primary observational studies Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as performing sample size and power calculation for studies, and creating randomization schedule per study design and relevant specifications Familiarity with specifications for CDISC and other analysis datasets Strong statistical programming skills with standard software, including SAS and R Strong communication (spoken and written) and problem-solving skills, and an ability to learn quickly Ability to communicate effectively, in non-technical terms, with project team members Ability to work well in a team as well as independently and take leadership roles with regard to methodological elements in projects Education and Experience Master's or Doctoral Degree in Statistics, Biostatics, Mathematics, Data Science or other quantitative fields. Language Skills Competent in written and spoken English Computer Skills SAS (Base, Stat, Graph, Macro) and R Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.