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
