NEW URGENT REQUIREMENT~ Programmer for SAS (with working knowledge on R & Python languages) Php 100&000 (Mid or Senior Level) Online Process Only!
J-K Network Services
Pasig, PH
14h ago
source : Bossjob

Company Profile : Global clinical company that provides high quality and full service clinical development solutions to pharmaceutical companies.

Position : Programmer for SAS

Location : Ortigas, Pasig City

Industry : Pharmaceutical Industry

Salary : Php 100,000 (Mid-Senior)

Working Schedule : Monday-Friday, 8am - 5 : 30 pm) Flexible Working Hours (still considered as dayshift, and there's a possible scheduled late night meeting) weekend-off

Benefits :

  • Daily meal subsidy (if reporting to the office)
  • HMO- Mx of 2 dependents 50% subsidized by the company
  • Monetized Leave
  • 15 Sick Leave
  • 15 Vacation Leave
  • Annual Salary Increase
  • 13th Month Pay
  • Holiday Pay
  • Overtime Pay
  • Job Responsibilities :

  • Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL).
  • Perform review and provide guidance on the development of the clinical database specification, data transfer agreement / specification, specification of tables, figures and listings (TFL) shells.
  • Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.
  • g. patient profiles, OPS reports.

  • Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study / Analysis Data Reviewer's Guide) for high complexity studies.
  • Serve as a programming project lead on a complex study (e.g. adaptive design, integrated safety / efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively.
  • Ensure budget and scope of project work remain aligned.

  • Manage the study documentation flow as per Worldwide SOP and other procedural documentation including timely document submission to eTMF.
  • Be able to describe and explain Worldwide documentation and eTMF requirements.

  • Contribute to department process improvement including creating and testing standard SAS Macros, maintaining the required validation documentation.
  • Provide consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements.
  • Develop and provide Statistical Programmers with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer.
  • Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL, R and Python) and other software applications (e.g. Excel, Visual Basic, Word).
  • Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical Practice, clinical data management, clinical / statistical reporting and regulatory submission requirements etc.

  • Act as subject matter expert for internal and external quality audits and inspections.
  • Ensure all activities performed by the study team are in compliance with Worldwide and sponsor quality requirements, relevant ICH and regulatory authority standards, e.
  • g. FDA 21 CFR Part 11, General Data Protection Regulation (GDPR).

  • Act as a mentor for junior department members.
  • Recruitment Process :

  • Paper Screening
  • Interviews
  • Written Assessment
  • This is for DIRECT HIRING

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  • Bachelor's Degree holder
  • Experience in using SAS Programming, SQL, R-Programming and with working knowledge in Python as well
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