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Manager, Statistical Programming
1 week ago
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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Manager, Statistical Programming:
3 weeks ago
Ascendis Pharma Palo Alto, United StatesThe 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 experiences in implementing and exec ...
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Senior Manager, Statistical Programming:
2 weeks ago
Ascendis Pharma Palo Alto, United StatesThe Senior 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 experiences in implementing a ...
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Manager, Statistical Programming: Job ID
2 weeks ago
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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Associate Director, Statistical Programming
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Cargo Therapeutics San Carlos, United StatesJob Description · Job DescriptionCARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart c ...
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Ascendis Pharma Palo Alto, United StatesJob Description · Job DescriptionThe Senior 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 ...
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Head of Statistical Programming
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Principal Statistical Programming
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Director, Statistical Programming
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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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Director, Statistical Programming
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Prothena Biosciences South San Francisco, United StatesPosition Overview: · This essential team member will be responsible for managing the statistical programming efforts for projects and studies under Alzheimer's Portfolio, including overseeing the developing, testing, maintaining, validating, and documenting SAS programs. · Respon ...
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Director, Statistical Programming
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Cytokinetics 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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Director, Statistical Programming
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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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Manager, Statistical Programming
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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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Sr. Manager, Statistical Programming
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Gilead Sciences Foster City, United States RegularJob Description · 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 – working relentlessly to develop therapies that help improve lives and to ensure access to these therap ...
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Sr. Manager, Statistical Programming
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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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BridgeBio Palo Alto, United StatesBridgeBio · 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 genetic science in a ...
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BridgeBio Palo Alto, United StatesBridgeBio · 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 genetic science in a ...
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Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
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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 ...
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Senior Director, Head of Statistical Programming
2 weeks ago
Alumis South San Francisco, United StatesJob Description · Job DescriptionSalary: · Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to su ...
Associate Director, Statistical Programming - Menlo Park, CA, United States - Corcept Therapeutics
Description
Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR).
In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing syndrome).Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases.
With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advance the possibilities of cortisol modulation.
What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.
Reporting to the Head of Statistical Programming, the Associate Director is responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses in support of clinical trial results.
This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department as applicableResponsibilities:Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications.
Review Statistical Analysis Plan, develop specifications, write and execute SAS programs for study data analysis and preparation for clinical study report.
Develop specifications, build and execute SAS programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.Develop SAS macros and tools for repeated program use for exploratory and post-hoc analyses.
Manage on-time and quality delivery of CRO-generated analyses results.
Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and and output displays.
Validate data and results of statistical analyses generated by CROs.Manage internal programming resources for study deliverables as applicable.
Stay current with regulatory requirements on CDISC and clinical regulatory programming standards.
Utilize CDISC implementation guides and industry validation software to check compliance of CDISC data packages (SEND, SDTM, and ADaM, and reviewer's guides).Evaluate CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness as applicable.
Participate in standards governance and developing biometric department operational processes as applicable.Preferred Skills, Qualifications or Technical Proficiencies:
In depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESSIn-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidancesIn-depth knowledge of Pinnacle 21 and how to address errors, warnings to generate acceptable reviewer's guides (SDRG, ADRG)
Knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine therapeutic areas preferredFamiliarity with data visualization tools (e.g Spotfire, Tableau, RShiny) a plusAbility to operate independently in unstructured situationsAbility to communicate technical information to a non-technical audiencePreferred Education and Experience:
Sc/B.A.
in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred)10+ years of experience in clinical trial development (late stage preferred)FDA/EMEA submission experience a plusDemonstrated ability for project management of statistical programming projects in clinical developmentExperience managing delivery of statistical programming projects by CROsAble to navigate uncertainty with creative problem solvingAbility to take a hands-on, "roll up your sleeves" approachThe pay range that the Company reasonably expects to pay for this headquarters-based position is $215,000- $250,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education."Applicants must be currently authorized to work in the United States on a full-time basis.
This position is based in Menlo Park, CA and will be onsite, typically 3 days per week.For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at:
Corcept is an Equal Opportunity EmployerCorcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.
Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.