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.
