CONTRACT – PRINCIPAL STATISTICAL PROGRAMMER
Position Summary:
The Principal Statistical Programmer’s role is to design, develop, and modify SAS programs to analyze and evaluate clinical data in accordance with statistical analysis plans, analyses, reports, and regulatory submissions. Maintains a leadership role on a study, project, or integration, interact with cross-functional teams at a high level to proactively determine programming tasks, manage timelines, assignments, and resource requirements and oversee study, project, or integration programming efforts to ensure the timely delivery of high-quality output according to company and industry standards. Represent statistical programming in the review of key study and project documents and data set or reporting specifications. Recognize inconsistencies and initiate resolution of data problems when necessary. Assist programming management with or be the lead on cross-functional process improvement initiatives and resource allocation. May oversee activities performed by FSP or contract programmers.
This position reports to the Senior Director, Statistical Programming. As an individual contributor, the successful candidate will be both a strong hands-on executor as well as strategic manager of internal and external partners.
Essential Duties and Responsibilities:
- Develop and review programming plans and specifications at project and study level for SDTM and ADaM data sets as well as the supporting documentation needed as required by CDISC standards
- Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs and macros
- Oversee and manage Statistical Programming CROs and their deliverables. Create validation plans and communication plans as required
- Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and safety reports
- Generate/Validate ad hoc data sets and TLFs on ongoing basis
- Build/Support a team of programmers to support ongoing pipeline expansion if any.
- Act as a liaison and represent the Programming Team and participate in intra-departmental meetings
- Collaborate and provide inputs to the Statisticians, Data Management, Medical writing, Clinical Science, R&D, Clinical Operations functions to achieve the Deliverables and bring the issues if any to their notice
- Assist in the development of relevant procedures and processes to ensure that statistical programs are properly documented and validated according to generally recognized industry and regulatory standards
- Supervise the activities of junior and contract statistical programmers and carry out line management responsibilities
- Carry out all activities according to SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensuring adherence to programming guidelines
- Review and interpret Statistical Analysis Plans and provide comments for assigned projects.
- Review key study documents produced by other functions (e.g: CRFs, data management plans, SAPs, clinical study reports, etc.)
Qualifications:
- Bachelor’s degree or equivalent experience with a computer science, mathematics, or statistics major preferred. In addition, must have a minimum of ten years of experience in the biopharmaceutical (or CRO) industry as a statistical programmer, and must have excellent SAS programming skills and experience programming datasets utilizing CDISC standards
- Must be able to work independently
- Outstanding communication skills (written and verbal)
- Strong leadership skills
- Input into and negotiate statistical programming timelines
- Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
- Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment