Teams at Maplight Therapeutics

Lead and oversee statistical programming for clinical development and regulatory submissions. Manage development/validation of SAS programs to produce SDTM/ADaM datasets and TLFs, ensure CDISC and regulatory compliance, partner with biostatistics, data management, clinical and regulatory teams, manage CRO/vendor relationships, and implement tools/process improvements. Perform hands-on SAS programming and support programming deliverables for submissions and study reports.

Lead statistical aspects of clinical projects: design sample size/power, author SAP and statistical protocol sections, oversee CRO statistical deliverables, contribute to CSR and regulatory documents, support publications, and collaborate with cross-functional clinical and regulatory teams.

Manage and operate the company contract management system; draft, review, negotiate, and administer clinical, supply, commercial, and other agreements; develop policies, templates, and workflows; train business users; manage outside counsel and vendors; and support legal, procurement, and finance systems integration while aligning contracting with company objectives.