Associate Director, Statistical Programming

Associate Director, Statistical Programming - Permanent - California

Ready to revolutionize biotech? Join a rising force that's redefining the future of healthcare and science!

Proclinical is seeking an Associate Director, Statistical Programming to join one of the most exciting Biotech's in the Bay Area.

The company already have successful Regulatory approvals and an extensive pipeline which is continuously progressing and growing where they are now keen to capitalise on by growing several business critical functions.

Primary Responsibilities:

The successful candidate will be 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.

Skills & Requirements:

• Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred)
• 8+ years of experience in clinical trial development (late stage preferred)
• In-depth knowledge of SAS BASE, MACRO, STAT
• In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances
• 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

The Associate Director's responsibilities will be:

• 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
• 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
• Manage internal programming resources for study deliverables as applicable
• 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)

Compensation:

• $190,000 to $220,000 per annum

If you are having difficulty in applying or if you have any questions, please contact George Breen at g.breen@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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