About the role
Position Summary
A Principal Statistical Programmer is an expert in management, technical oversight, and quality of statistical programming activities related to the analyses of clinical trial data ensuring timelines and company strategic objectives are met. A CDISC SDTM specialist is a key team member on CDISC submission topics; provide industry leading CDISC expertise and programming leadership. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable.
Essential Functions
- Lead all aspects of the statistical programming activities including efficient programming techniques.
- Lead all aspects of creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
- Contribute to and review of statistical analysis plans and analysis datasets specifications and prepare the electronic submission of clinical trial data to regulatory authorities.
- Create specifications, develop, and validate of CDISC SDTM and regulatory deliverables (Define.xml, SDTM aCRF, cSDRG).
- Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions). Communicate with regulatory agencies regarding electronic data submission requirements.
- Participate effectively as an ad-hoc member on clinical development and regulatory submission teams.
- Provide effective solutions for complex statistical programming tasks.
- Create and manage projects and study electronic subdirectories ensuring consistency in structure.
- Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
- Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project
- Conduct resource planning and budgeting for statistical programming activities of a project.
- Participate in development of new processes or revision of existing processes.
- Keep current with new statistical programming techniques and technical advancements.
- As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. Train junior staff in more complex statistical programming techniques.
- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
- Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
Education & Experience
- Bachelor’s Degree in Statistics/Biostatistics, Computer Science, Mathematics or other field of study with at least 10+ years of relevant experience is required, OR
- Master’s Degree in Statistics/Biostatistics, Computer Science, Mathematics or other field of study with at least 8+ years of relevant experience is required.
- 5+ years of experience as a statistical programmer in the pharmaceutical industry is preferred.
- Expert in CDISC STDM guidelines
- Expert in CDISC SDTM regulatory deliverables (Define.xml, SDTM aCRF, cSDRG)
- Experience as a lead statistical programmer on several concurrent projects
Knowledge, Skills, & Abilities
- Working knowledge of the clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
- Technically strong with regard to statistical programming processes and activities.
- Highly proficient in SAS.
- Excellent English verbal and written communication skills; good organizational and interpersonal skills.
Working Environment / Physical Environment
- This position works onsite or remotely depending on the candidate’s geographic location.
- Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
- Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
- Lift and carry materials weighing up to 20 pounds.