- Leads one or multiple studies
- Consistently works with cross- functional areas
- Directs and controls multiple deliverables
- In-depth knowledge of functional area, industry standards and company goals
- 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
- 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
- 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
- Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline
- Minimum of 6 years 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
- 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
- Vendor management experience
- Excellent communication and interpersonal skills #LI-CS1 #LI-Hybrid
-
Head of Statistical Programming
2 weeks ago
EPM Scientific - Phaidon International San Francisco, CA, United StatesWe recently partnered with a leading Oncology company focused on on treating cancer in ways that are much more likely to get approved and actually help patients. Our client is looking for a Head of Statistical Programming for their highly anticipated program with indications in ...
-
Principal Statistical Programming
2 weeks ago
Edwards Lifesciences San Francisco, United StatesImagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientif ...
-
Manager, Statistical Programming
1 week ago
Bristol Myers Squibb Brisbane, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
BridgeBio Pharma, Inc. San Francisco, CA, United StatesAbout BridgeBio BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in geneti ...
-
Infinity Ventures Black Point-Green Point, United StatesThree degrees at once · Are you a high school graduate looking for an alternative to university? Then join our Abiturient program with a focus on purchasing after school and get on the fast track. In just 18 months, you will complete the commercial training as a wholesale and for ...
-
Program Specialist Sbdc
36 minutes ago
Dominican University Of California San Rafael, United States**About the Marin SBDC**: · **Essential Duties and Responsibilities**: · - Work closely with the Director to maintain the high-quality standards of this program and assist in developing new systems for greater efficiency · - Conduct intakes for new client signups, collect informa ...
-
IT Support Engineer
1 week ago
Radiant Innovations San Rafael, United StatesJoin our team in San Rafael · Make it happen · Do you have a passion for technology and customer service? Are you looking for a dynamic and challenging role in a fast-paced environment? Then we want you to be a part of our team in San Rafael. · As a Technical Support Specialist, ...
-
MarinHealth Medical Center Greenbrae, United States**Trauma Registry Specialist, Trauma Registration, Full-Time, Days**: · **Greenbrae, CA**: · **ABOUT MARIN HEALTH**: · Come and be a part of our healing team at the award-winning Marin Health Ranked in the top 3% of general hospitals in the country, we have made great strides sin ...
-
Research Analyst
1 day ago
University of California San Francisco San Francisco, United StatesThe incumbent will have an integral role in data management, including data cleaning, report preparation, data dictionary creation, database QA, and software/hardware maintenance and backups. · - The incumbent will work closely with other members of the Pulmonary Division and Pro ...
-
Data Reporting and Analytics Consultant Iv
4 days ago
Kaiser Permanente Oakland, United States**Job Summary**: · In addition to the responsibilities listed below, this position is also responsible for overseeing all phases of data management, quality control, and reporting; programming in analytical programming languages (may include SAS, SQL, SPSS, R, Python, etc.); taki ...
-
R Developer
1 week ago
Infodrive Systems , Inc San Francisco, United States**Title: R Developer** · **Location: San Francisco, CA, Plano, TX or Charlotte, NC or Atlanta, GA or Chicago, IL** · **Duration: 12+ Months** · - Bachelor's/master's degree in engineering, Computer Science, Mathematics, IT (or equivalent experience) · - At least 3+ years of exper ...
-
Oni-orisan Lab
36 minutes ago
UC San Francisco Academic San Francisco, United States**Application Window**: · **Open date**:April 22, 2024 · **Next review date**: Tuesday, May 7, 2024 at 11:59pm (Pacific Time) · **Final date**:Wednesday, Oct 22, 2025 at 11:59pm (Pacific Time) · Applications will continue to be accepted until this date, but those received after t ...
-
Meta San Francisco, United States**Research Scientist, Demography and Survey Science, University Grad Responsibilities**: · - Develop a research agenda and drive research projects from end-to-end · - Collaborate with cross-functional teams across the company to define relevant research questions · - Design and d ...
-
Program Assistant
1 week ago
Contra Costa Community College District Pleasant Hill, United States**Program Assistant (Welcome and Connect Services)** · **Posting Number**: · **Location**: Diablo Valley College · **Salary**: $19.75/hour · **Position Definition**: · To schedule and provide a variety of college services for assigned programs in order to attract, retain and sup ...
-
Data Reporting and Analytics Consultant Iv
1 week ago
Kaiser Permanente Oakland, United StatesRemote from any KP location in CA, OR, CO, WA, GA, MD, VA, HI or D.C. Only. · **Job Summary**: · This individual contributor is primarily responsible for driving strategic data-informed decisions, gathering data and information on targeted variables in an established systematic f ...
-
Data Reporting and Analytics Consultant Iv
1 week ago
Kaiser Permanente Oakland, United States**Job Summary**: · This individual contributor is primarily responsible for driving strategic data-informed decisions, gathering data and information on targeted variables in an established systematic fashion, preparing data for analytic efforts, and interpreting data analyses. · ...
-
Director, Facilities and Capital Projects
1 week ago
University of California Berkeley Berkeley, United StatesDirector, Facilities and Capital Projects (0480U) Job College of Computing, Data Science, and Society (CDSS) About Berkeley · At the University of California, Berkeley, we are committed to creating a community that fosters equity of experience and opportunity, and ensures that st ...
-
Data Reporting and Analytics Consultant Ii
1 week ago
Kaiser Permanente Oakland, United States**Job Summary**: · This individual contributor is primarily responsible for assisting senior employees in supporting data-informed decisions, assisting with data and information gathering for targeted variables in an established systematic fashion, and supporting data preparation ...
-
Research Data Analyst
6 days ago
University of California San Francisco San Francisco, United StatesWorks on research data reporting assignments that are of moderate diversity in scope. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. · - We are looking for a Research Data Analyst with strong quantit ...
-
Actuarial Analyst, Experienced
1 week ago
Blue Shield of California Oakland, United States**Your Role · The Actuarial Provider Strategies team helps design and implement value-based care (VBC) payment models, which include Accountable Care Organizations (ACOs) and other innovative alternative payment models (APMs) to improve the affordability and quality of care our m ...
Senior Manager, Statistical Programming - Novato, United States - Ultragenyx Pharmaceuticals Inc.
Description
Position Summary:
ultracurious - Apply your biggest ideas in courageous ways
Reporting to Director of Statistical programming, the Senior Manager acts as statistical programming lead with accountability for various Ultragenyx studies and deliverables; This position will provide leadership and support to project teams on all statistical programming matters with help from the supervisor.
Lead one or more studies 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 one or multiple studies and will lead the programming submission related activities.
Work Model:
Flex:
This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
Requirements:
