Associate Director, Biostatistics

OverviewMannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.Job SummaryThe Associate Director of Biostatistics will be responsible for oversight and input on statistical design, data analysis, and regulatory interactions for all MannKind programs. The ideal candidate combines deep technical expertise with collaborative leadership and brings a strong track record of supporting clinical development. This position will act as the leading statistician on multiple studies/projects across different therapeutic areas. This is a unique opportunity for a biostatistics leader who’s looking to make a significant impact in a fast-moving, high-growth environment.ResponsibilitiesProvide input to protocol and study design, statistical sections and study objectives, adaptive designs, endpoints, estimands, sample size computation and power estimationsDevelopment of Randomization Plans, including generation of mock and final randomization lists. Collaborate with team regarding implementation of specifications for randomization system set upParticipate in the development of Bioanalytical Plans, PK Analysis Plans and PK Data Transfer AgreementsProvide key input to project DSMB Charters, Blinding and Unblinding Plans, Statistical Analysis Plans, and study drug compliance calculationsReview of protocol deviations in conjunction with populations assignments; review TLF and shells; review and approval of CSRs; review and approval of overall submission packages (SDTM and ADaM datasets)Work with Statistical Programmer to develop specifications for datasets in conjunction with the SAP and submission packageReview of key results and statistical assessment in preparation of publications and regulatory submissions (IBs, Protocols, Clinical Summaries, IRs, Briefing Documents, DSURs, Integrated Safety and Efficacy Summaries, etc.). Attend prep meetings and participate in Agency meetings as requestedProvide statistical expertise in development of MannKind data collection standardsProvide input into annual budget estimationsManage CRO and contract statisticiansAttend project and study team meetings as needed. Support and participate in activities related to regulatory requests and meetings as needed. Close communication with functional manager is expectedProvide statistical expertise by identifying potential issues, providing recommendations and bring in external statistical experts for relevant issues as neededEnsure compliance with regulatory guidelines, Good Clinical Practice (GCP), and industry standards in statistical analysis and reportingQualificationsMaster's Degree, PhD or MS in Statistics, Biostatistics or other scientific disciplineMinimum of 10 years of experience in statistical analysis for clinical trials, preferably in the pharmaceutical or clinical research industryProficiency in statistical analysis software (e.g., SAS)Experience with statistical programming and the development of TLFExcellent communication skills, with the ability to effectively communicate statistical concepts to non-statisticiansStrong collaboration skills with cross-functional teamsFamiliarity with regulatory requirements for clinical trial conduct and reportingFlexible and able to support a variety of studiesAbility to act independently and with initiativeKnowledge of EU regulatory agencies, FDA/ISO guidelines and industry standard practices regarding Biostatistics #J-18808-Ljbffr

Created: 2025-10-06