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Statistical Programmer

2.00 to 7.00 Years   Chennai   09 Apr, 2021
Phoenix Human Capital Pvt Ltd
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Roles and Responsibilities

  • To maintain a high level of professionalism, performance, productivity and quality.
  • To undergo Regulatory trainings, ICH GCP and 21 CFR Part 11 trainings.
  • To read and understand the Study documents (Protocol, eCRF, Dataset specifications, SAP, Mock shells etc.).
  • To complete the Project Specific Trainings and maintain appropriate documentation.
  • To perform role of primary and/or validation programmer for all assigned studies.
  • To annotate eCRF using Dataset specifications and create annotated CRF (aCRF).
  • To review CRF annotations.
  • To identify and document the data issues through appropriate trackers and report to the Lead Programmer.
  • To develop SAS programs/macros, templates and utilities for data cleaning and reporting if required.
  • To perform Reconciliation of the External data.
  • To develop SDTM and ADaM specifications as per the client requirements.
  • To develop/validate CDISC compliant datasets (SDTM/ADaM) using the Dataset specifications.
  • To create Define.xml, SDRG and ADRG documents.
  • Responsible for all Statistical Programming activities including Self-Validation checklists.
  • Efficient in both production and QC of analysis datasets, tables, listings and figures.
  • To ensure all programs are compliant with the SOPs and project specific guidelines.
  • To perform First Time Quality Control on reports created.
  • To provide SAS programming support for Data Management.
  • To communicate with the Lead Programmer on the status of daily assigned tasks and study related questions.
  • To support the study documentation on the assigned project in accordance with SOPs to ensure traceability and regulatory compliance.
  • To provide advanced technical expertise and work under a minimal supervision to support various programming activities.
  • To ensure clear and proactive communication with the project teams to clarify requirements and specifications, then start the project tasks accordingly.
  • To support junior programmers working on the project and support training requirements for the trainees.
  • Self-learning and development on department specific skill sets.
  • To complete training documentation on timely basis.
  • To support/assist in audit specific requirements for internal/external audits.
  • Desired Candidate Profile
  • Good communication skills, both written and verbal.
  • Good language skills with an eye for grammar/punctuation.
  • Good time management and planning skills.
  • Good team working characteristics, capable of working in cross-functional teams.
  • Ability to multitask and prioritize work.
  • Paying close attention in detail, timeliness and quality.
  • Significant knowledge of drug development and clinical research.
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Keyskills :
drug developmentproject administrationsas programmingdata cleaningproject teamsgcpdata managementlanguage skillssasquality control21 cfrstatistical programmingsapreportingsdtm

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