Principal Statistical Programmer

2 months ago

Bengaluru Karnataka, India Veranex, Inc. Full time

Veranex is the leading service provider for medtech companies. Our global team of experts help clients anticipate challenges and find solutions throughout the development and commercial lifecycle. Together, we accelerate new technologies to market and improve patient outcomes.
- Minimum Requirement:

- Master’s degree or international equivalent in statistics, computer science or life sciences and 7-9 years of relevant work experience
- In-depth knowledge of clinical research and the drug development process
- Advanced domain knowledge of various therapeutic areas
- Advanced programming skills
- Excellent written and oral communication skills
- Excellent attention to detail
- Ability to solve complex problems
- Advanced ability to effectively manage multiple tasks and projects
- Ability to lead and coordinate small teams
- Having wide-ranging experience, uses professional concepts to resolve complex issues in creative and effective ways.
- 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.
- Manages resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
- Trains and mentors new or junior programmers.
- Provides advanced technical expertise and support to the programming team.
- Participates in business development activities by preparing Request for Proposal and effort estimation.
- Interacts with sponsors/client as key programming contact.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results. Networks with key contacts outside area of expertise.
- Determines methods and procedures for new assignments and may coordinate activities of other team members.

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