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$229k–$270k/yr
Full-time
bachelor degree, postgraduate degree
Posted 5d ago
~40 hrs/week
Responsibilities
The Associate Director is responsible for planning, executing, and ensuring the quality of SAS programming for clinical trial statistical analyses. They also manage CRO deliverables, ensure CDISC compliance for regulatory submissions, and develop internal programming infrastructure.
Requirements
Candidates must have at least 10 years of experience in clinical trial development and in-depth knowledge of SAS and CDISC standards. A bachelor's degree in a scientific or technical field is required, with a master's degree preferred.
Full job description
For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
As a member of the Statistical Programming team, 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 applicable.
Responsibilities:
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, define.xmls 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
Works with line manager and/or Head of Statistical Programming to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets
Preferred Skills, Qualifications and Technical Proficiencies:
In depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS
In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
In-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 preferred
Familiarity with data visualization tools (e.g Spotfire, Tableau, RShiny) a plus
Ability to operate independently in unstructured situations
Ability to communicate technical information to a non-technical audience
Preferred 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 plus
Demonstrated ability for project management of statistical programming projects in clinical development
Experience managing delivery of statistical programming projects by CROs
Able to navigate uncertainty with creative problem solving
Ability to take a hands-on, “roll up your sleeves” approach
The pay range that the Company reasonably expects to pay for this headquarters-based position is $229,300 – $269,800; 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.
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.
Corcept 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.
Pioneering the discovery and development of cortisol modulators.
Industry
Biotechnology Research
Company size
501-1,000 employees
Founded
1998
Headquarters
Redwood City, California
LinkedIn followers
73,767
Total funding
$119M
We’ve been unlocking the potential of cortisol modulation for more than 25 years.
We’re leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.
In 2012, we received FDA approval of a groundbreaking cortisol receptor blocker and the first approved treatment for hypercortisolism (Cushing’s 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 advancing 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.
Offices: 101 Redwood Shores Pkwy, Redwood City, California 94065, US
How much do Technology jobs in Redwood City, CA pay?
Based on 262 listings with disclosed salaries, most technology jobs in Redwood City, CA pay between $130k–$260k per year. Individual offers vary with seniority, company size, and specialization.
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There are currently 334 open technology positions in Redwood City, CA listed on Clera. New openings are added daily as companies post roles.
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