Jobs 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.

Lead and standardize Clinical Program Management across the clinical development portfolio. Oversee program planning, execution, governance, risk mitigation, cross-functional alignment, and resource management. Develop the PM team, implement best practices and enterprise tools, and support decision-making to ensure consistent, high-quality execution from preclinical into clinical stages.

Lead clinical data management from study start-up through database lock. Develop data and validation plans, manage Medidata Rave setup, perform data cleaning and reconciliation, generate quality metrics and listings, support regulatory submissions, and collaborate with clinical, biostatistics, and regulatory teams to ensure data integrity and compliance.