Proclinical Staffing
(Associate) Director, Statistical Programming
Proclinical Staffing, San Francisco, California, United States, 94199
(Associate) Director, Statistical Programming – Permanent – San Francisco Bay Area
Proclinical is seeking an (Associate) Director, Statistical Programming for a rapidly growing biotechnology company based in the San Francisco Bay Area.
Primary Responsibilities In this role, you 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.
The position is based in the San Francisco Bay Area at the company’s HQ in a hybrid work schedule.
Skills & Requirements
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)
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
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
The (Associate) Director, Statistical Programming will:
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 output displays
Please contact
Phu Huynh
at
(+1) 646-779-7961
or
p.huynh@proclinical.com .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Primary Responsibilities In this role, you 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.
The position is based in the San Francisco Bay Area at the company’s HQ in a hybrid work schedule.
Skills & Requirements
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)
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
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
The (Associate) Director, Statistical Programming will:
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 output displays
Please contact
Phu Huynh
at
(+1) 646-779-7961
or
p.huynh@proclinical.com .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#J-18808-Ljbffr