CP SDTM level 2

Date: May 26, 2023

Location: Morrisville, NC, US, 27560

Company: Cytel Software Corporation

As a Senior SDTM Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs. 

 

  • In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting.  Knowledge of SAS is required, may include SAS, R, Python, etc..
  • Expert knowledge of Define.xml, SDTM aCRF, cSDRGs.
  • Expert knowledge of data structures (e.g., CDISC SDTM, CDISC CT) and their implementation.
  • Experience in working with SDTM Conformance Checks
  • SDTM mapping is a must
  • Technical Data Management experience and experience working on a clinical trial.
  • 3-5 years experience
  • Preparing and validating submission packages, i.e. define.xml, Reviewers Guide
  • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
  • Being adaptable and flexible when priorities change

 

Qualifications and Experience:

 

  • BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • Must have relevant industry experience
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Ability to implement the latest CDISC SDTM  standards (production/validation).
  • Experience and or familiar with Pinnacle21
  • Submissions experience utilizing define.xml and other submission documents such as SDRG
  • Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease strongly desirable.
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

 

As a Senior SDTM Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM) to support or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development, or Medical Affairs. 

 

  • In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting.  Knowledge of SAS is required, may include SAS, R, Python, etc..
  • Expert knowledge of Define.xml, SDTM aCRF, cSDRGs.
  • Expert knowledge of data structures (e.g., CDISC SDTM, CDISC CT) and their implementation.
  • Experience in working with SDTM Conformance Checks
  • SDTM mapping is a must
  • Technical Data Management experience and experience working on a clinical trial.
  • 3-5 years experience
  • Preparing and validating submission packages, i.e. define.xml, Reviewers Guide
  • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
  • Being adaptable and flexible when priorities change

 

Qualifications and Experience:

 

  • BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • Must have relevant industry experience
  • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
  • Strong SAS data manipulation, analysis and reporting skills.
  • Ability to implement the latest CDISC SDTM  standards (production/validation).
  • Experience and or familiar with Pinnacle21
  • Submissions experience utilizing define.xml and other submission documents such as SDRG
  • Experience supporting Medical Affairs, Immunology, Cardiovascular, Oncology, Infectious Disease strongly desirable.
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines.
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

 


Nearest Major Market: Raleigh