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Corcept Therapeutics · 2 weeks ago

Associate Director, Statistical Programming

Redwood City, CA

Full-time

Onsite

Lead/Staff, Director/Executive

$205K/yr - $253K/yr

10+ years exp

Corcept Therapeutics is a leader in the research and development of cortisol modulators, with a focus on treating serious diseases through innovative solutions. The Associate Director of Statistical Programming will oversee the planning, execution, and quality of SAS programming for statistical analyses in support of clinical trials, ensuring compliance with CDISC standards and regulatory requirements.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

SAS BASECDISC SDTMCDISC ADaMStatistical programmingClinical trial designData visualization toolsProject managementCreative problem solvingTechnical communication

Required

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

Ability to operate independently in unstructured situations

Ability to communicate technical information to a non-technical audience

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

Ability to navigate uncertainty with creative problem solving and take a hands-on, “roll up your sleeves” approach