Associate Director, Biostatistics

Role Summary

The 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.

Responsibilities

• Provide input to protocol and study design, Statistical sections and study objectives, adaptive designs, endpoints, estimands, sample size computation and power estimations
• Development of Randomization Plans, including generation of mock and final randomization lists. Collaborate with team re: implementation of specifications for randomization system set up
• Participate in the development of Bioanalytical Plans, PK Analysis Plans and PK Data Transfer Agreements
• Provide key input to project DSMB Charters, Blinding and Unblinding Plans, Statistical Analysis Plans, and study drug compliance calculations
• Review 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 package
• Review 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 requested
• Provide statistical expertise in development of MannKind data collection standards
• Provide input into annual budget estimations
• Manage CRO and contract statisticians
• Attend 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 expected
• Provide statistical expertise by identifying potential issues, providing recommendations and bring in external statistical experts for relevant issues as needed
• Ensure compliance with regulatory guidelines, Good Clinical Practice (GCP), and industry standards in statistical analysis and reporting

Qualifications

• Master's Degree, PhD or MS in Statistics, Biostatistics or other Scientific discipline
• Minimum of 10 years of experience in statistical analysis for clinical trials, preferably in the pharmaceutical or clinical research industry
• Proficiency in statistical analysis software (e.g., SAS)
• Experience with statistical programming and the development of TLF
• Excellent communication skills, with the ability to effectively communicate statistical concepts to non-statisticians
• Strong collaboration skills with cross-functional teams
• Familiarity with regulatory requirements for clinical trial conduct and reporting
• Flexible and able to support a variety of studies
• Ability to act independently and with initiative
• Knowledge of EU regulatory agencies, FDA/ISO guidelines and industry standard practices regarding Biostatistics

Education

• Master's Degree, PhD or MS in Statistics, Biostatistics or other Scientific discipline