TK-Chain®
Website:
tk-chain.com
Job details:
Eteraflex Connects is a specialized contract research organization (CRO) delivering top-tier clinical trial services to pharmaceutical, biologic, biotechnology, and medical device/diagnostic companies. Eteraflex Connects provides a technology-enabled service offering that combines deep clinical services expertise with the technology clients need to be successful in their clinical trials, supporting programs from compound selection through Phase I-IV studies.
Position Summary
The Principal Statistical Programmer is responsible for coordinating and programming of clinical data analyses in support of clinical trials. The role partners closely with biostatisticians, data management, project leaders, and sponsors to deliver high-quality, validated programming output that supports statistical analysis plans (SAPs), regulatory submissions, and clinical study reports. This position also contributes to process improvement, mentors junior programmers, and may serve as a Project Leader on project teams.
Responsibilities
· Coordinate and program clinical data analyses in support of assigned clinical studies.
· Analyze and evaluate clinical data, recognize inconsistencies, and initiate resolution of data problems.
· Program using the SAS language to support clinical analysis and reporting activities.
· Implement statistical analysis plans (SAPs) and produce analysis datasets, tables, listings, and figures.
· Consult, as needed, in the design and development of clinical trials, protocols, and case report forms (CRFs).
· Validate the work of other programmers and perform independent QC of programming deliverables.
· Ensure the maintenance of programming documentation (e.g., descriptions of programs and validation records).
· Interact regularly with statisticians, data management personnel, project leaders, and sponsors.
· Communicate project status, risks, and resource issues to management in a timely manner.
· Investigate and propose initiatives for improving efficiency, standards, and programming quality.
· Serve as Project Leader on project teams when assigned, managing timelines, budgets, and deliverables.
· Contribute to and take part in client evaluations, visits, and bid defenses.
· Provide mentoring and technical guidance to junior programming staff.
Qualifications
· Bachelor's degree required; Master's degree preferred in a scientific discipline.
· SAS Advanced Programming Certificate preferred.
· Minimum 10+ years of relevant work experience.
· Minimum 10+ years of experience in drug development and/or clinical research.
· Thorough knowledge of computer systems, applications, and operating systems.
· Strong analytical skills with the ability to simplify complex issues into understandable concepts.
· Demonstrated ability to mentor junior staff.
Skills
· Strong written and verbal communication skills, including a good command of the English language.
· Proficiency with various computer applications such as Word, Excel, and PowerPoint.
· Expert knowledge/experience of SAS/Base, especially macros, arrays, formats, and ODS.
· Expert knowledge of SAS/STAT and SAS/GRAPH.
· Familiarity with basic statistical principles to effectively interact with biostatisticians.
· Excellent written skills and ability to interpret and implement table manuals and statistical analysis plans.
· Advanced knowledge of drug development principles related to the production of databases and summary tables, such as CDISC standards (SDTM/ADaM).
· Ability to author validation plans and oversee validation of programming deliverables.
Primary Skills
· ESS
· JAD
· Remedy
· Shell Scripting
· Veritas
Location: Bangalore, Delhi and Hyderabad on Fulltime basis
Work Schedule: UK Business Hours (Afternoon-Evening IST)
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