Senior Statistical Programmer - Remote SDTM/ADaM Lead

Cytel; Frankfort (KY); On-site; USD 95,000 - 140,000; Full time

Job summary

Cytel Inc. is seeking a Senior Statistical Programmer to contribute to one or more Phase I-IV clinical trials while working remotely.

You will leverage advanced SAS programming and CDISC SDTM/ADaM expertise to develop, validate and deliver analysis datasets, tables, listings and figures for safety and efficacy data. You will collaborate with cross-functional teams across the global sponsor landscape, support submissions, and assume lead duties when required.

Qualifications

• Bachelor’s degree in Statistics, Computer Science, Mathematics or related field.
• At least 8 years of SAS programming with clinical trial data; 6+ years with a master's.
• Study lead experience preferred.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing CDISC SDTM/ADaM standards.
• Strong QC/validation skills.
• Good ad-hoc reporting skills.
• Proficiency in Efficacy analysis.
• Experience with drug development life cycle and submissions (define.xml).
• Experience supporting immunology, respiratory or oncology studies is a plus.
• Excellent analytical and troubleshooting skills.
• Ability to deliver quality outputs on tight timelines.
• Ability to work with a globally dispersed team.

Responsibilities

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data
• Applying strong understanding/experience of Efficacy analysis
• Creating and reviewing submission documents and eCRTs
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties when called upon
• 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

Skills

Data manipulation

Analysis and reporting

Ad-hoc reporting

Efficacy analysis

QC/validation

Communication with cross-functional团队

Education

Bachelor's degree in Statistics, Computer Science, Mathematics

Tools

SAS

CDISC SDTM/ADaM

Job description

Cytel Inc. is seeking a Senior Statistical Programmer to contribute to one or more Phase I-IV clinical trials while working remotely.

You will leverage advanced SAS programming and CDISC SDTM/ADaM expertise to develop, validate and deliver analysis datasets, tables, listings and figures for safety and efficacy data. You will collaborate with cross-functional teams across the global sponsor landscape, support submissions, and assume lead duties when required.