Associate Director, Biostatistics - REMOTE

Proclinical is seeking a remote Associate Director, Biostatistics for a cutting-edge pharmaceutical company.

As the Associate Director, you will be responsible for contributing to trial designs, crafting statistical sections of protocols, preparing statistical analysis plans, and providing insightful interpretations of clinical trial data.

Must be eligible to work in the US.

Job Responsibilities:

• 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).

Skills and Requirements:

• Ph.D. in Biostatistics, Statistics, or equivalent, with at least 7 years of experience in pharmaceutical biostatistics; alternatively, an MS with at least 10 years of relevant experience.
• Possess excellent written and oral communication and presentation skills.
• Proficient in SAS programming.
• Demonstrated interest in and basic understanding of biology and biological processes, including RNAi.
• Experience in clinical development through Phase 3, including NDA submission.
• 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.
• Proficiency in R programming language and other statistical software, including EAST.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Paula Bonilla at +(1) 305-929-0913 or p.bonilla@proclinical.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.

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