Senior Manager, Statistical Programming
Why Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.
To achieve this goal, our vision is to lead the future of rare disease medicine.
For us, this means going where other biopharma companies won t go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments.
We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx.
We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives, in and outside of work.
Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
Position
Summary:
ultracurious Apply your biggest ideas in courageous waysLeads one or multiple studiesConsistently works with cross- functional areasDirects and controls multiple deliverablesIn-depth knowledge of functional area, industry standards and company goalsReporting 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:
Manage all programming activities on one or multiple projects/studies across all therapeutic areas, both internally and externally by CROsProvide leadership in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectivesFunction as a positive role model for setting high expectations for quality, creativity and project ownershipWorks 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 reportingWork with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriateEnsure proper implementation of Company data model and submission and analysis data standardsEnsure consistency and efficiency in programming practicesimplementation of standards and project managementFoster team building and a collaborative work environmentAct 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 needsRequirements:
Master s Degree in Statistics, Computer Science, Mathematics, Engineering or related disciplineMinimum of 6 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industryAdvanced SAS programming skills and experience in other statistical software, such as RExperience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologiesSelf-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer managementExcellent organizational skills and ability to prioritize tasksVendor management experienceExcellent communication and interpersonal skills #LI-CS1 #LI-HybridThe typical annual salary range for this full-time position is listed below.
This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting.
The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range$145,500 $179,800 USDFull Time employees across the globe enjoy a range of benefits, including, but not limited to:
Generous vacation time and public holidays observed by the company Volunteer days Long term incentive and Employee stock purchase plans or equivalent offerings Employee wellbeing benefits Fitness reimbursement Tuition sponsoring Professional development plans Benefits vary by region and countryUltragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws.
Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs.
Applicants can request an accommodation prior to accepting a job offer.
If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.
com.
See our CCPA Employee and Applicant Privacy Notice.
See our Privacy Policy.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
To achieve this goal, our vision is to lead the future of rare disease medicine.
For us, this means going where other biopharma companies won t go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments.
We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx.
We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives, in and outside of work.
Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.
Position
Summary:
ultracurious Apply your biggest ideas in courageous waysLeads one or multiple studiesConsistently works with cross- functional areasDirects and controls multiple deliverablesIn-depth knowledge of functional area, industry standards and company goalsReporting 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:
Manage all programming activities on one or multiple projects/studies across all therapeutic areas, both internally and externally by CROsProvide leadership in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectivesFunction as a positive role model for setting high expectations for quality, creativity and project ownershipWorks 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 reportingWork with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriateEnsure proper implementation of Company data model and submission and analysis data standardsEnsure consistency and efficiency in programming practicesimplementation of standards and project managementFoster team building and a collaborative work environmentAct 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 needsRequirements:
Master s Degree in Statistics, Computer Science, Mathematics, Engineering or related disciplineMinimum of 6 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industryAdvanced SAS programming skills and experience in other statistical software, such as RExperience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologiesSelf-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programmers and customer managementExcellent organizational skills and ability to prioritize tasksVendor management experienceExcellent communication and interpersonal skills #LI-CS1 #LI-HybridThe typical annual salary range for this full-time position is listed below.
This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting.
The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives.
Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range$145,500 $179,800 USDFull Time employees across the globe enjoy a range of benefits, including, but not limited to:
Generous vacation time and public holidays observed by the company Volunteer days Long term incentive and Employee stock purchase plans or equivalent offerings Employee wellbeing benefits Fitness reimbursement Tuition sponsoring Professional development plans Benefits vary by region and countryUltragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws.
Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs.
Applicants can request an accommodation prior to accepting a job offer.
If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.
com.
See our CCPA Employee and Applicant Privacy Notice.
See our Privacy Policy.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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