Executive Director, Statistical Programming

March 4

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Exelixis

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Exelixis is a biotechnology and pharmaceutical company focused on developing cancer treatments through innovative research and development. The company is committed to advancing oncology by creating impactful cancer medicines, including biotherapeutics and small molecule therapies. Exelixis places a strong emphasis on clinical trials, collaborations, and a diverse range of treatment modalities, aiming to provide hope to cancer patients. Additionally, Exelixis is dedicated to sustainability, diversity, and community support, as reflected in their corporate values and practices.

1001 - 5000 employees

Founded 1994

🧬 Biotechnology

💊 Pharmaceuticals

💰 $65M Post-IPO Equity on 2012-02

📋 Description

•Manage a statistical programming team to develop and validate SAS programs for oncology drug development. •Oversee all aspects of a SAS programming team. •Set employee goals and conduct performance assessments. •Define, develop, and implement good programming practices. •Adhere to FDA regulations regarding training records and SOPs. •Remain current on emerging regulations. •Create or modify processes for improvement. •Define training curriculum for new employees. •Identify needs in technical knowledge for the programming function. •Partner with biostatisticians and clinical data management staff. •Communicate progress and milestones effectively.

🎯 Requirements

•BS/BA degree in related discipline and a minimum of 18 years of related experience. •MS/MA degree in related discipline and a minimum of 16 years of related experience. •PhD in related discipline and a minimum of 15 years of related experience. •Equivalent combination of education and experience. •At least 16 years of related experience and/or a combination of experience and education/training. •Experience in the Biotech/Pharmaceutical industry. •A minimum of 10 years of clinical trial programming experience. •Experience recruiting, hiring, and supervising programmers. •Experience authoring SOPs and work instructions. •Experience in oncology and study Phases 1-III and NDA/BLA submissions highly desirable. •Good managerial and organizational skills. •Good written and verbal communication skills. •Knowledge of appropriate FDA regulations, industry standards, and guidance documents. •Understanding of the clinical research process, trial designs, and the development of protocols and analysis plans. •Expert knowledge of the SAS programming language, including SAS Base/Macro/STAT/Graph/ODS. •Proficient in computer skills relevant to programming and analysis environments. •Expert knowledge of CDISC standards and FDA data-submission standards.

🏖️ Benefits

•401k plan with generous company contributions. •Group medical, dental and vision coverage. •Life and disability insurance. •Flexible spending accounts. •Discretionary annual bonus program. •Opportunity to purchase company stock. •Receive long-term incentives. •15 accrued vacation days in their first year. •17 paid holidays including a company-wide winter shutdown in December. •Up to 10 sick days throughout the calendar year.