- Lead statistical programming activities as the product lead for one or multiple compounds to support timely and high-quality assembly, reporting, and submission of data on all clinical studies in assigned product(s)
- Lead process improvement initiatives that facilitate standards, infrastructure, and process enhancements across Biometrics, decide on their designs and implementation, and provide advice as a contributor on other such efforts
- Provide technical leadership and ensures adequate statistical programming support for an indication/disease area
- Assist Statistical Programming head to ensure successful implementation of Statistical Programming strategies and efficient execution of the statistical analyses for an indication/disease area
- Provide in-depth guidance, oversight or hands-on programming on assigned products or similar projects to ensure accuracy, completeness, quality, and timely delivery of statistical programming deliverables supporting clinical trial analysis, reporting, and regulatory or other stakeholder review
- Review, and comment on CRFs, edit checks and other study related documents
- Participate in the review of statistical analysis plans, draft TFL specifications, design analysis data sets, and provide inputs for SDTM mapping
- Participate in vendor qualification/selection and monitor vendor performance. Oversee CRO's deliverables
- Develop and contribute to company SOPs, work instruction, best practices, and other guidance documents for the entire department and beyond; provide impactful feedback into such documents authored by others
- Keep abreast of literature and advancements in SAS
- Bachelor's degree in a statistics, computer science, mathematics, or related fields with 12+ years of biopharmaceutical experience as a Statistical Programmer
- 5+ years of supervisory experience
- Extensive knowledge and understanding of SAS programming concepts and skills
- Strongly demonstrated proactivity and superb attention to detail
- Thorough understanding of and hands-on experience with CDISC SDTM and ADaM standards
- Experience leading integrations (ISE/ISS), regulatory submissions, or similar
- Experience contributing directly to departmental budget and resource planning exercises
- Demonstrated proficiency in communicating and presenting complex ideas to varied audiences
- Strong leadership skills and team work spirit, communicating effectively
- Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment
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Director, Statistical Programming
2 weeks ago
Cytokinetics South San Francisco, United StatesWe view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that ...
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Director, Statistical Programming
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Director, Statistical Programming
2 weeks ago
Cytokinetics, Incorporated South San Francisco, United StatesCytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle p ...
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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 ...
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Manager, Statistical Programming
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Bristol-Myers Squibb Brisbane, United States**Working 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 ...
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Gilead Sciences, Inc. Foster City, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
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Manager, Statistical Programming
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Ascendis Pharma Palo Alto, United StatesJob Description · Job DescriptionThe Manager, Statistical Programmer will be expected to provide timely support to the study team on all programming matters according to project strategies. This role is focused on supporting team. The incumbent should have hands-on skills and exp ...
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Clinical Data Manager
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Vice President Clinical Operations
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Director, Statistical Programming - South San Francisco, United States - Cytokinetics
Description
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health span of people with cardiovascular and neuromuscular diseases of impaired muscle function.
This role will report to the Sr Director, statistical programming and provides deeply impactful leadership on operational and staffing strategies, processes, and quality and efficiency improvements across the entire Statistical Programming department.
Responsibilities
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Salary Pay Range
$230,000-$280,000 USD
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do - all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at:
Cytokinetics is an Equal Opportunity Employer
Director, Statistical Programming professionals in South San Francisco
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Kuo-Ching Chang
Data Scientist