Remote Associate Director

Summary

Join our team as an Associate Director of Biostatistics and contribute to delivering solutions for people living with opioid use disorder. As a key member of the cross-functional team, you will be responsible for all statistical activities related to Medical Affairs, Clinical Development, and HEOR tactics.

Requirements

• Ph.D. in Statistics/Biostatistics or related discipline. Masters considered based upon experience
• At least 7 years of experience in biostatics or related roles in the pharmaceutical or biotech industry
• Advanced computer and internet skills, including knowledge of MS applications (such as Word, PowerPoint, Teams, Excel), SharePoint
• Proficient in statistical programming, coding, and design/sample size software (e.g. SAS)
• Proven experience with working in a hybrid or remote environment

Responsibilities

• Performs all statistical analyses for the preparation of publications, including manuscripts, posters and oral presentations, and contributes to their publication as an author or key stakeholder
• Serves as study statistician for clinical trials and provides high quality decision support
• Contributes to interventional, observational, post-marketing, and RWE study design and protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
• Works collaboratively with internal and external (e.g., CRO, medical communications vendors) team members to coordinate the planning and execution of statistical deliverables
• Conducts statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
• Authors statistical analysis plans (SAPs) for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and develops shells for tables, figures and listings
• Reviews case report form (CRF) designs to ensure data collection will provide the necessary data to perform all statistical analyses for primary, secondary, and exploratory endpoints
• Designs and specifies randomization schedules; reviews and approves test randomization lists
• Provides statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents
• Programs or reviews analysis dataset specifications
• Performs QC/QA of statistical deliverables including validation of key analysis results
• Performs ad hoc, post hoc, and exploratory statistical analyses
• Contributes to clinical study reports (CSRs), including authoring of statistical methods and interpretation of the study results
• Leads statistical activities in support of IND/NDA/MAA or other regulatory submissions
• Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs
• Contributes or leads standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts
• Authors biostatistics SOPs and contributes to the development of SOPs for related activities