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DBO_SAS/CDM in ,

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DBO_SAS/CDM

Diverse Lynx India Pvt. Ltd. IND (Onsite) Full-Time
JOB DESCRIPTION OF – SAS Programmer

Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.
A minimum of 7 years of total experience with at least 5 years of experience in Statistical programming and/or design and analysis of Phase I to Phase IV clinical trials in a Contract Research Organization or Pharmaceutical or Biotechnology company
  • Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations.
  • Good knowledge of GCP, Good Programming Practices, ICH-E3, ICH-E9 and other regulatory guidance documents (e.g. USFDA and EMEA)
  • Understanding client's requirement and providing all the required statistical inputs on, SAP, Mock Shells, Tables, Listings, Figures or any other statistical programming deliveries
  • Good understanding of the statistical programming domain and related processes
  • Assists with developing, monitoring, and enforcing productivity and quality standards along with related documentations
  • Coordinating with the project management in meeting the timeline and defining/ capturing the metrics for monitoring and maintaining the quality and productivity
  • Good verbal and written communication skills coupled with good organizational skills

Technical:
  • Strong Analytical and programming Skills using statistical software SAS or equivalent with understanding of development and/or execution of SAS macros
  • Knowledge of R will be an added advantage
  • Should have worked on generating and validating tables, listings and figures
  • Should have worked on Derived datasets/Analysis Datasets/ADaM/SDTM/TLF
  • More complex review (programs with high risk)
  • Programming and review of outputs for DSUR,PSUR, publications
  • Exposure on Exploratory analyses is an added advantage
  • Programming and review of analysis data sets.
  • Provide training and guidance to lower level and new staff.
  • Experience in submission packages (Define.xml, SDRG, ADRG, P21 reports)

Compliance:
• Adherence to SOPs and GPP
  • Quality and adherence to timelines.
  • Self-motivation and self-learning
  • Achievement orientation
  • Relationship building ability
  • Inclination towards being process driven


Role – Project Data Manager/Study Data Manager
Designation : Data Analyst/ Team Lead (Individual Contributor)- Client Facing role.

Essential skills
• Ability to proactively communicate ownership of studies
• Confidence to understand the data and clearly communicate issues to team
• Critical thinking to identify data review and cleaning needs
• Being able to enable an environment of open and honest communication and critical
thinking within study team
• Ability to influence internal team to meet timelines by holding stakeholders accountable
• Ability to work with different personalities to ensure effective and efficient issue
resolution
• Willingness to seek out information to accomplish goals
• Team-oriented
• Desire to be a productive contributor to the study team
• Continuous improvement and innovation mind-set
• Proactive communication
Operational
Responsibilities
• Coordinate and perform data review activities to identify erroneous, missing, incomplete,
or implausible data to ensure the highest quality database delivery to prevent post-lock
changes.
• Owner of overall data integrity plan for the study including
– All expected data present
– Preventing unlocks
– Stats Lite (i.e. stats mindset for DS)
– Stats Listings
– Identification of critical data
• Owner of IDRP
– Facilitate IDRP development meeting with study team
– Communicate with study team on manual reviews that can be programmed and
identify critical data points
– Manage IDRP approval
– Execute data review per IDRP
• Owner of Clinical Database Specification (CDS)-cllinical data science
– Define LSH edit checks
– Manage the approval/testing documentation for CDS
– When appropriate provide feedback on the quality of the test scripts to originator
• Create and manage edit checks and visualizations
– Coordinates with programming and study team on edit checks finalization
– Check with study team for any evolving data needs
• Ensure critical checks of the data happens early in the study to avoid last minute quality
issues
• Knowledgeable of study protocol to provide primary feedback to SD/DWA on
consistency and completeness of clinical database/study design
• Engage with stats, stats programming, remote monitor, and safety to understand the
data needs and align study team
• Manage Post-Production Changes/Amendments for IDRP and CDS
• Contribute to HoS- Health Of Study
• Support stakeholders with ad hoc review needs
• Manage assigned activities to meet milestone dates and escalate to PL(Project Lead) when timelines
at risk
• Log any action issues into DS Hub and resolve outstanding issues assigned to CDR
• Ask questions to get information needed to meet end goal

Exp: DA (3+ yrs)
TL : 6-9yrs.
For 5+ yrs of experience : ecrf spec creation, edit check spec creation and their Testing is must + good knowledge of study conduct & lock.

Recommended Skills

  • Analytical
  • Biotechnology
  • Business Process Improvement
  • Clinical Trials
  • Clinical Works
  • Critical Thinking

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