Essential Duties and Job Functions:
Acts as lead statistical programmer for a project.
May participate in sub-team meetings as a representative of Statistical Programming group.
Provides consistency and quality assurance across various studies.
Independently identifies issues in the analysis plan from previous experience and knowledge.
Collaborates with Biostatisticians and Clinical Research Scientists on studies and helps define the data set.
Able to defend the results of their analysis.A theft or
Demonstrates strong project management skills including ability to anticipate time, resources and staffing required to successfully complete a study.
Demonstrates significant contribution to an NDA.
A promotion from this position is dependent on the business need of the organization.
Attend a conference or class related to SAS, eCTD, CDISC
Application Development, Clinical Programming, Biostatistics
Works collaboratively with Biostatisticians, Statistical Programmers, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
Identifies potential issues in statistical analysis plans and proposes solutions.
Assesses the quality of analysis data and performs cross-study analyses.
Uses internal macros or writes SAS® macros to automate statistical table, figure, and listing production.
Assists in the preparation of submissions of electronic data (e.g., SAS® data sets) to regulatory agencies.
Independently develops analysis file programs.
Works as a primary programmer for multiple Phase 1-3 studies and as a secondary programming contact for one or more Phase 1-3 studies.
Contributes to strategic initiatives.
Excellent verbal and written communication skills and interpersonal skills are required.
Has thorough knowledge of clinical trial study design and electronic data submission requirements.
Must be able to work independently on multiple concurrent projects.
Must be capable of attending study team meetings as the primary statistical programming contact.
Knowledge, Experience and Skills:
6 years of experience and a BS degree in Biostatistics, Computer Science or equivalent.
2 years of experience and a MS degree in Biostatistics,/Computer Science or equivalent.
1 year of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent.
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