Masters degree or international equivalent in statistics, computer science or life sciences and and 5-7 years of relevant work experience
In-depth knowledge of clinical research and the drug development process
Strong programming skills
Strong written and oral communication skills
Excellent attention to detail
Ability to solve moderate to complex problems
Strong ability to effectively manage multiple tasks and projects
Ability to lead and coordinate small teams
A seasoned professional with full understanding of area of specialization.
Resolves a wide range of issues in creative ways. Fully qualified level of the role.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in area of expertise.
Works independently; receives minimal guidance on day-to- day work and new projects or assignments.
Roles and Responsibilities:
Develops programming plan for statistical outputs (datasets, tables, figures, and listings), supporting clinical study reports, regulatory submissions, and publications. Gathers requirements and implements data models according to specifications and project timelines (Study Data Tabulation Model (SDTM)/Analysis Dataset Model (ADaM)). Develops CDISC (Clinical Data Interchange Standards Consortium) compliant datasets according to dataset specifications and client requirements.
Develops statistical outputs (tables, listings, and figures) in accordance with Statistical Analysis Plan, Mock shells, and client requirements.
Ensures all programs and datasets are compliant with CDISC, client standards, SOPs, regulatory requirements, and project specific guidelines as applicable.
Read and understand study documents (Protocol, eCRF, dataset specifications, SAP, Mock shells, etc.) as applicable.
Develops and maintains the SAS programs/macros, creates templates and utilities for data cleaning and reporting and performs reconciliation of the external data.
Performs role of primary and/or validation programmer for all assigned studies.
Supports and assists with audit specifical requirements for internal/external audits.
Creates Define.xml, SDRG and ADRG documents.
Develops SDTM and ADaM specifications compliant to CDISC standards and according to client requirements.
Develops programming plan for statistical outputs, supporting clinical study reports, regulatory submissions, and publications.
Develops and maintains SAS programs/macros, templates and utilities for data cleaning and reporting. Reconciles external data.
Annotates case report forms (CRF) using dataset specifications and create annotated CRF.
Performs quality control on internally created statistical outputs to achieve first time right (FTR) outputs.
Initiates protocol and SAP discussion.
Develops and performs quality control on programs, datasets, tables, figures, listings, and any other ad- hoc reports as required.
Provides advanced technical expertise to programming team.
Trains and mentors new or junior programmers.
May manage resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations
