Associate Director, Statistical Programming

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Position

The Associate Director of Statistical Programming will report directly to Head of Statistical Programming and will lead and oversee the clinical trial analysis and reporting of assigned project(s).  Additional key representative responsibilities will include, but not necessarily be limited to, the following:

• Lead and manage statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency
• Manage CRO to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards by reviewing CRO deliverables and perform acceptance check and validation
• Perform hands-on clinical programming activities such as patient profiles generation
• Perform hands-on SAS programming to generate TFLs to support ad hoc requests and decision making
• Collaborate with cross-functional teams and external alliances for all programming-related activities; ensure successful and effective coordination and communications
• Ensures quality of deliverables by consistently applying analysis and reporting standards, and driving compliance with regulatory requirements, corporate and departmental SOPs and work practices
• Create SAS macros/applications to streamline processes
• Drives the development and implementation of innovative strategies and technologies for clinical trial programming
• Develops unambiguous and robust programming specifications for internal and external programming work
• Provide technical leadership and guidance for programming team and vendors around project conventions, standards, practices, and specifications
• Reviews planning documents (e.g., statistical analysis plans, data presentation plans, data review plans) to ensure clarity, integrity and compliance with requirements and standards

Qualifications

• Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience
• Minimum of 8 years of clinical/statistical programming experience within pharmaceutical clinical development with experience that includes leading programming efforts to support regulatory filings (e.g., US, EU)
• Minimum of 3 years of experience in managing technical professionals in a regulated environment
• Experience of leadership in building and maintaining programming environment, infrastructure, and processes
• Extensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor’s capabilities and ensuring the desired high-quality deliverables
• Extensive knowledge of SAS software (i.e., Base, Stat, Graph components) and general computing techniques in addition to knowledge of R or other statistical software packages
• Significant knowledge of the drug development process, clinical trial methodology, statistics, and relevant regulatory requirements for drug approval
• Demonstrated ability to operate and lead in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise.
• Able to adapt quickly to the changing needs of the organization
• Able to organize multiple work assignments and establish priorities
• Excellent verbal and written communications skills; able to communicate proactively and effectively

Fit with Nurix Culture and Values

• Strong team orientation; highly collaborative
• Solutions and results-oriented focus
• Hands-on approach; resourceful and open to diverse points of view

Application Process

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.

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