Principal Biostatistician - Anywhere, US Office-based or Remote-based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of \"Bringing Clinical Trials to Life,\" we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Principal Biostatistician performs the data analysis with supervision for assigned clinical studies. Works closely with the clinical team, project Sponsor, data manager, other Biostatisticians and programmers to analyze and present the data based on Sponsor specifications. He/she develops, creates, verifies/validates and maintains the programs for assigned projects in compliance with standard operating procedures. Specific tasks would include: Maintains the full-scope of responsibility for assigned projects: ensures on-time delivery, communicates the status of projects to internal teams and project Sponsors, executes quality assurance procedures on work produced by others and ensures statistical analysis is being done according to specifications. Serves as lead statistician for assigned projects, coordinates and monitors work assignment of other supporting Biostatisticians and programmers. Creates/maintains analyses, tables/listings/figures Writes/Reviews Statistical Analysis Plan (including Mock tables/listings). Reviews Case Report Forms for assigned projects to ensure data is collected appropriately to achieve the analysis defined in the protocol. Ensures table, listing and statistical analysis programming is being done according to Sponsor specifications (where not defined, within company standards). Creates/QC specifications for, and programs, derived data sets. Performs programming validation and ensures all Quality Control efforts have been followed. Assists in writing and/or reviewing Statistical Reports. Reviews protocol, providing feedback as well as adding to the methods section and providing input on project design issues, endpoint definition and sample sizes. Provides sample size calculation and documentation. Generates Randomization Schedules. Works closely with Sponsor to ensure a high quality, timely delivery of tables/listings/figures and statistical reports. Bibliography research for statistical analysis techniques Represents Biostatistics in communication with Sponsors. Provides statistical guidance for other company Biostatisticians. Leads specialized Biostatistics development projects as requested by Management Assists Sponsors in developing regulatory strategies. Provides Sponsors with statistical representation at regulatory meetings. Qualifications Master's degree or equivalent in statistics, mathematics or related field of project and a minimum of 12 years related experience or equivalent combination of education and experience. Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations. Advanced proficiency in BASE SAS, or other statistical software is advantageous, but not required. Understands the sequence of running programs to ensure up-to-date data and to troubleshoot, debug programming problems and to identify data trends. Nonverbal symbolism experience (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Good proficiency in Microsoft Word, Excel, and PowerPoint, Access. Effective verbal and writing skills; English + local language, if relevant. If you're passionate about bringing clinical trials to life, we encourage you to apply today! Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.
Associated topics: bioinformatics, biometrics, biostatistics, data analyst, data science, sas, statistics