Principal Statistical Programmer

🔥 11 minutes ago

🇺🇸 United States – Remote

💵 $125.5k - $165.5k / year

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Organize and manage a statistical programming group supporting multiple drug development programs • Collaborate on resource planning, allocation, and assignment of programmers • Address resourcing needs to adequately staff projects • Contribute to departmental process and standards initiatives, including macro tools, innovation, and CDISC standards implementation • Contribute to development and implementation of the programming resource algorithm • Oversee internal and contract programmers and provide guidance, mentoring, and career development support • Contribute to selection and management of CROs and strategic outsourcing providers • Oversee work supporting clinical trials, ad hoc analysis requests, and data validation • Serve as a technical resource and advise on complex programming tasks and standards • Provide managerial support, leadership, training, and mentoring to employees • Support development of therapeutic area user guides following CDISC standards • Represent Statistical Programming on cross-functional teams and process improvement initiatives • Contribute to department culture building and engagement • Perform other duties as assigned

🎯 Requirements

• Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject, or equivalent related experience • Minimum 4+ years of clinical research and development programming experience using SAS • Expert-level SAS programming, including developing original code and modifying existing code for complex programming assignments and analyses • PC literacy and Microsoft Office skills, including Outlook, Word, Excel, and PowerPoint • Knowledge of SDTM and ADaM standards • Experience writing CDISC-standard dataset specifications and creating SDTM and ADaM datasets from specifications • Experience leading teams supporting FDA, EMEA, and CDE filings • Solid knowledge and hands-on experience with CDISC standards, including CDASH, SDTM, and ADaM • Experience leading or working with centralized Statistical Programming teams • Experience developing and implementing statistical programming standards and procedures • Experience with the drug development process in preclinical, early, late-stage, and/or observational settings, including oncology trials • Fundamentals of project planning and management • Ability to adapt to changing priorities, maintain attention to detail, work under pressure, and take initiative on unfamiliar tasks • Ability to establish and articulate a team plan • Accountability for individual and team performance, with sound judgment and decision-making • Excellent verbal and written communication skills and ability to collaborate effectively • Licenses or certifications: N/A

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits