We are seeking a skilled Statistical Programmer to join our team. The ideal candidate will have advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADAM) to support or lead one or more phase I-IV clinical trials.
About the Role
As a Senior Statistical Programmer, you will be responsible for performing data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy (ISS / ISE), utilizing SAS programming. You will also generate and validate SDTM and ADAM datasets / analysis files, and tables, listings, and figures (TLFs). Additionally, you will perform production and QC / validation programming, generate complex ad-hoc reports utilizing raw data, and apply strong understanding / experience of efficacy analysis.
Responsibilities
- Data Manipulation and Analysis : Perform data manipulation, analysis, and reporting of clinical trial data using SAS programming.
- Dataset Generation and Validation : Generate and validate SDTM and ADAM datasets / analysis files, and tables, listings, and figures (TLFs).
- Production and QC / Validation Programming : Perform production and QC / validation programming.
- Ad-Hoc Reporting : Generate complex ad-hoc reports utilizing raw data.
- Efficacy Analysis : Apply strong understanding / experience of efficacy analysis.
- Submission Documents : Create and review submission documents and ECRTs.
- Communication : Communicate with internal cross-functional teams and clients for project specifications, status, issues, or inquiries.
- Lead Duties : Perform lead duties when called upon.
Requirements
Bachelor's Degree : Bachelor's degree in Statistics, Computer Science, Mathematics, or related field.SAS Programming Experience : At least 8 years of SAS programming experience working with clinical trial data in the pharmaceutical and biotech industry with a bachelor's degree or equivalent.Study Lead Experience : Study lead experience, preferably juggling multiple projects simultaneously preferred.SAS Data Manipulation and Analysis Skills : Strong SAS data manipulation, analysis, and reporting skills.CDISC SDTM / ADAM Standards : Solid experience implementing the latest CDISC SDTM / ADAM standards.QC / Validation Skills : Strong QC / validation skills.Ad-Hoc Reporting Skills : Good ad-hoc reporting skills.Efficacy Analysis Proficiency : Proficiency in efficacy analysis.Drug Development Life Cycle Experience : Familiarity with drug development life cycle and experience with the manipulation, analysis, and reporting of clinical trials' data.Submission Experience : Submissions experience utilizing Define.xml and other submission documents.Preferred Qualifications
Immunology, Respiratory, or Oncology Studies Experience : Experience supporting immunology, respiratory, or oncology studies would be a plus.