Associate Director/Director, Statistical Programming

Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: February 22, 2021

Job Description:

Associate Director/Director, Statistical Programming Ultragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. The company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are typically no approved therapies treating the underlying disease.-- Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives. Come join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding. Position Summary ultracurious - Apply your biggest ideas in courageous ways-- Reporting to the Head of Statistical programming and Biostatistics, the Associate Director/Director of Statistical Programming acts as statistical programming lead with accountability for Ultragenyx Gene Therapy product and study deliverables; This position will provide leadership and support to project teams on all statistical programming matters. Lead one or more projects for all programming deliverables through the project milestones from study start-up to regulatory submission and approval and post marketing support. Collaborate with statisticians and programmers across to ensure high quality and timely statistical programming deliverables. This position will spearhead the statistical programming activities for multiple studies and will lead the programming submission related activities.-- Responsibilities, including but not limited to:

• Manage all programming activities on one or multiple projects/studies across all therapeutic areas, both internally and externally by CROs
• Provide leadership in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives
• Function as a positive role model for setting high expectations for quality, creativity and project ownership
• Works collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory, Project Management and other functions/staff to meet project deliverables and timelines for statistical data analysis and reporting
• Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers)
• Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate
• Participate in the statistical programming training as appropriate
• Ensure proper implementation of Company data model and submission and analysis data standards
• Ensure consistency and efficiency in programming practices
• implementation of standards and project management
• Foster team building and a collaborative work environment
• Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. Ensure project milestones are met to facilitate decision-making and address business needs Requirements:
  • Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline
  • Minimum of 5 years for Associate Director (10 for Director) of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry
  • Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus
  • Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
  • Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer management
  • Excellent organizational skills and ability to prioritize tasks
  • Excellent communication and interpersonal skills Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact--Talent Acquisition--by calling:--(415) 483-8800--or by--emailing--us at--talentacquisition@ultragenyx.com . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to:--talentacquisition@ultragenyx.com .

Keywords: Ultragenyx Pharmaceutical, Novato , Associate Director/Director, Statistical Programming, Executive , Novato, California