Job Description
H1B transfer, stock, bonus, and relo.
- Onsite San Diego
- Min. 8 years of statistical programming experience in Pharma/Biotech
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Function/Scope:
As a Clinical Statistical Programming, you play a key role in developing, implementing and evaluating statistical programming standards and processes. You will be responsible for the production of selected project related Tables, Listings, and Figures (TLF), patient profiles, and integrated summaries of efficacy and safety data as required. Programming responsibilities include development of macros, and advanced statistical programming, supporting complex projects. You also hold responsibilities for maintenance and management of the departmental program codes, documentations, and outputs.
Duties and Responsibilities Include But Are Not Limited To:
Oversee CROs for the statistical programming deliverables.
Ensure consistency of approach for all studies assigned to the CRO partner.
Review adherence to timelines.
Identify & resolution of systemic staffing, process, or quality issues that could impact individual study deliverables.
Qualification of statistical programming vendors.
Oversight of process assessments.
Provide statistical programming expertise to the project team and study team(s).
Provide specifications for deliverables to CRO Partner.
Oversee statistical programming CRO partner for timeliness, quality and cost.
Review study and project related documents that require statistical programming input.
Consult in the design and development of clinical trials to ensure compliance with regulatory requirements, sponsor and CRO SOPs and working practice documents, including CRF design and review.
Provide status updates to study teams and acts as an interface between the study team and the statistical programming CRO Partner.
Responsible for collaborating on the design and documentation of clinical databases.
Responsible for developing, implementing and evaluating statistical programming standards and processes.
Ensure production and delivery of all statistical programming related deliverables as defined in the SOPs.
Contribute to the tracking of metrics and performance measures both internally and externally.
Perform functional process assessments of statistical programming partner CROs.
Provide within study and between study comparisons of statistical programming timelines across products.
Review study level cost bids against standard statistical programming CRO partner pricing or historical bids for non-statistical programming partner CROs or vendors.
Develop and test SAS Software programs to complete complex analyses and data cleaning with no supervision.
Develop, test, and validate Tables Listings, and Figures.
Develop and test SAS Software programs using SAS to manipulate and/or import external data into Analysis SAS data sets or export SAS output or data to other computer files for delivery to other departments.
Develop SAS Software programs to create derived parameters and output, derived data sets, or other required advanced data manipulation.
Prepare documents to describe SAS Software programs for documentation.
Contribute to budget forecasting and regular cost accrual processes.
Communicate closely with statistical programming partner CRO contacts outside of the project and study team in order to ensure that the statistical programming partner CRO is acting as an extended workforce.
Performs other duties as required.
Desired Knowledge and Abilities:
Working knowledge in SAS, Excel.
Knowledge in clinical trials and drug development.
Familiar with CDISC standards.
Being able to communicate with other functions and explain statistical programming aspect effectively.
Education & Experience:
Bachelor degree is required; and advanced degree is preferred.
Experience in pharmaceutical/biotech industry is required, and oncology experience is a plus.
Regulatory submission experience is a plus.
Job Tags
H1b