Full-Time

Associate Director

Statistical Programming

Confirmed live in the last 24 hours

Corcept Therapeutics

Corcept Therapeutics

201-500 employees

Develops cortisol modulation therapies for diseases

Biotechnology

Compensation Overview

$215k - $250kAnnually

Senior, Expert

Menlo Park, CA, USA

Required Skills
Tableau
Data Analysis
Requirements
  • 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
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.

At Corcept Therapeutics, we specialize in pioneering selective glucocorticoid receptor antagonists. Our focused efforts extend to over 30 active studies aimed at addressing the detrimental impacts of excess cortisol in endocrine, metabolic, oncologic, and psychiatric conditions. We are dedicated not only to advancing medical science but also to prioritizing the well-being of our team, ensuring a collaborative and supportive work environment that fosters innovation and professional growth.

Company Stage

IPO

Total Funding

$119.1M

Headquarters

Menlo Park, California

Founded

1998

Growth & Insights
Headcount

6 month growth

13%

1 year growth

24%

2 year growth

46%