Senior Statistical Programmer
Functional area: Clinical Development
Provide statistical programming and analysis in support of clinical trials of pharmaceuticals. Capable of directing and coordinating the activities of Statistical Programming personnel assigned to projects and monitors progress on programming deliverables independently with little supervision. Support the Data Sciences function with statistical analyses, including generating analysis datasets, tables, listings and figures for clinical trials. Support the data management function with integrity checks, and quality audits. Support the clinical operations function with ad hoc reports and testing of vendor-supplied applications. Support medical affairs group with publication development. Assist in preparing datasets and documentation for use in NDA submissions.
- Perform all SAS programming required for clinical trial analysis and reporting.
- Design, code and document analysis datasets to support analyses.
- Design, code, document and generate tables, listings, and graphs as specified in the Statistical Analysis Plan, or on an ad hoc basis.
- Act as lead programmer for a phase 1, 2 or 3 study, including leading a team of programmers.
- Capable of designing and programming standard clinical reports, independent of statistician
- Oversee outsourced studies.
- Design & develop SAS macros and other utilities to expedite SAS programming activities.
- Participate in statistical program quality control activities.
- Collaborate with other departments, such as Data Management, Clinical Operations and Project Management, to ensure a successful execution of clinical trials.
- Support publication efforts.
- Participate in review process of study documents such as the CRFs, edit specifications written by Data Management, Statistical Analysis Plans and data presentation plans.
- Program data edit checks, as necessary, to facilitate Data Management's data cleaning activities.
- Develop and maintain the infrastructure for project files of SAS datasets and SAS programs.
- Ensure all programming activities are conducted according to Ironwood’s standard operating procedures.
- Strong SAS programming skills required, with expertise in SAS/Base, and SAS Macros.
- Strong analytical and problem-solving skills, with the ability to process scientific and medical data.
- 3+ years of programming experience, including at least 2 years statistical programming with clinical trial data.
- Understanding of standards specific to clinical trials, such as CDISC and MedDRA.
- Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues.
- Able to work independently, good organizational and time management skills, with the ability to multi-task.
- BS or equivalent experience
- 5+ of experience programming with clinical trial data
- Understanding of statistical tests used in clinical trials.
- Proficient in SAS/Graph and SAS ODS Graphics.
- Proficient in programming in R/S Plus.
Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.
Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.