Job Description :
Job title : Clinical Statistical Programming Lead
Location : San Diego,CA
Full time
Function/Scope:
As a Clinical Statistical Programmer, 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:
Oversees CROs for the statistical programming deliverables.
Ensures consistency of approach for all studies assigned to the CRO partner.
Reviews 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.
Provides statistical programming expertise to the project team and study
team(s
Provides specifications for deliverables to CRO Partner.
Oversees statistical programming CRO partner for timeliness, quality and
cost.
Reviews study and project related documents that require statistical
programming input.
Consults 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.
Provides 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.
Ensures production and delivery of all statistical programming related
deliverables as defined in the SOPs.
Contributes to the tracking of metrics and performance measures both
internally and externally.
Performs functional process assessments of statistical programming partner
CROs.
Provides within study and between study comparisons of statistical
programming timelines across products.
Reviews study level cost bids against standard statistical programming CRO
partner pricing or historical bids for non-statistical programming partner
CROs or vendors.
Develops and test SAS Software programs to complete complex analyses and
data cleaning with no supervision.
Develops, tests, and validates Tables Listings, and Figures.
Develops and tests 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.
Develops SAS Software programs to create derived parameters and output,
derived data sets, or other required advanced data manipulation.
Prepares documents to describe SAS Software programs for documentation.
Contributes to budget forecasting and regular cost accrual processes.
Communicates 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 and Experience:
Bachelor degree is required; advanced degree is preferred.
Experience in pharmaceutical/biotech industry is required; oncology
experience is a plus.
Regulatory submission experience is a plus.