Team Leader
Description:
Team Leader
JOB DESCRIPTION – SAS Programmer
Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.
A minimum of 6+ 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
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 reviewing 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.
SNo
Primary Skill
Proficiency Level *
Rqrd./Dsrd.
1
SAS Programming
PL3
Required
eam Leader
JOB DESCRIPTION – SAS Programmer
Graduate/Post-Graduate in Statistics/Mathematics/Computer Science/Life Sciences.
A minimum of 6+ 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
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 reviewing 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.
* Proficiency Legends
Proficiency Level Generic Reference
PL1 The associate has basic awareness and comprehension of the skill and is in the process of acquiring this skill through various channels.
PL2 The associate possesses working knowledge of the skill, and can actively and independently apply this skill in engagements and projects.
PL3 The associate has comprehensive, in-depth and specialized knowledge of the skill. She / he has extensively demonstrated successful application of the skill in engagements or projects.
PL4 The associate can function as a subject matter expert for this skill. The associate is capable of analyzing, evaluating and synthesizing solutions using the skill.
Schedule: Full-time
Shift: Day Job
Travel: No