Associate Director, Biostatistics

Associate Director of Biostatistics - Permanent - Remote within US Proclinical Staffing are partnered with a truly exciting Mid-Sized Global Pharma in their search for an Associate Director, Biostatistics. Primary Responsibilities: The business specialize across a diverse set of Rare Diseases with their work culminating in 9 products successfully approved and now hold a renowned pipeline of several upcoming submissions. Skills & Requirements: D. in Biostatistics, Statistics, or equivalent, with at least 5 years of experience in pharmaceutical biostatistics; Proficient in SAS programming Previous experience as a lead statistician for a compound. Understanding of ICH GCP (International Council for Harmonisation - Good Clinical Practice) and general knowledge of industry practices and standards. Familiarity with CDISC (Clinical Data Interchange Standards Consortium) standards, such as SDTM (Study Data Tabulation Model), ADaM (Analysis Data Model), and CDASH (Clinical Data Acquisition Standards Harmonization). Experience representing sponsors in meetings with US FDA and international regulatory authorities. Experience in designing and conducting adaptive trials. Possess excellent written and oral communication and presentation skills. The Associate Director of Biostatistics' responsibilities will be: Act as a representative of the biostatistics team in cross-functional meetings, driving the clinical development of drug candidates, and offering valuable input on clinical development plans. Collaborate closely with Clinical Development, Regulatory, and Clinical Operations Expertise Areas to design well-structured and effective clinical trials. Author statistical sections of clinical trial protocols while seeking guidance and input from internal and external experts. Contribute to or develop statistical analysis plans to ensure robust data analysis. Work collaboratively with Data Management, Clinical Development, and Clinical Operations teams to design electronic case report forms (eCRFs). Provide expert statistical guidance throughout the ongoing trials to ensure accurate data analysis and interpretation. Collaborate with Statistical Programmers to summarize and analyze trial data. Draft ADS (Analysis Data Sets) and ad hoc analysis specifications. Play a key role in preparing clinical study reports and other regulatory documents, such as DSURs (Development Safety Update Reports) and Briefing Documents. Represent company in meetings with regulatory authorities, Key Opinion Leaders, partners, and other stakeholders. Contribute to the development of scientific articles that summarize data collected in company's trials. Participate in various activities and meetings to provide support to the Biostatistics and Development Team as required. Offer statistical consultation to Research & Preclinical colleagues on their work. Manage statistical and programming support from external Contract Research Organizations (CROs). Compensation: $205,000 to $215,000 per annum. If you are having difficulty in applying or if you have any questions, please contact George Breen at g.breenproclinical.com Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.