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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical programming, project management, and regulatory compliance, with a strong focus on SAS proficiency and adherence to ICH-GCP standards. Capable of leading global teams and ensuring quality control in statistical deliverables.
Highest-signal resume keywords
Statistical Programming LeadSAS ProficiencyProject ManagementICH-GCP KnowledgeRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical ProgrammingSASData QCDataset SpecificationsStatistical Analysis PlansMock-ShellsProcess-Supporting DocumentsElectronic SubmissionsCDISC KnowledgeRegulatory Knowledge
Soft Skills
Analytical SkillsCommunication SkillsOrganizational SkillsTime ManagementPresentation Skills
Industry Keywords
SOPs/Guidelines21 CFR Part 11Regulatory InspectionsQuality Improvement InitiativesGlobal Programs
About the role
Key responsibilities & impact- Fill the Statistical Programming Lead role on projects
- Input into and negotiate statistical programming timelines and ensure adherence
- Coordinate and lead statistical programming teams to complete studies within timelines and budget
- Monitor project resourcing and budgets and identify scope changes
- Coordinate project start-up activities, global programs, tracking spreadsheets, and required documentation
- Review statistical analysis plans, mock-shells, and database set-up specifications
- Interact with sponsors and internal stakeholders regarding statistical programming issues
- Assist project teams in resolving daily work problems
- Produce and QC derived datasets, tables, figures, and data listings using efficient programming techniques
- Produce and QC dataset specifications, process-supporting documents, and submission documentation
- Ensure QC of process and technical activities in accordance with quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements
- Maintain and expand local and international regulatory knowledge
- Provide training and mentorship to staff and project teams
- Maintain study documentation for traceability and regulatory compliance
- Participate in audits and regulatory inspections as required
- Lead or participate in process and quality improvement initiatives
- Provide consultancy to internal and external sponsors
- Represent Parexel at sponsor marketing and technical meetings
- Apply knowledge of CDISC, 21 CFR Part 11, and electronic submissions
Requirements
What you’ll need- Educated to degree level in a relevant discipline and/or equivalent work experience
- Competent in written and oral English
- Excellent analytical skills
- Proficiency in SAS
- Extensive knowledge and understanding of the programming and reporting process
- Knowledge of SOPs/Guidelines, ICH-GCP, and applicable local and international regulations such as 21 CFR Part 11
- Ability to learn new systems and function in an evolving technical environment
- Strong project management and organizational skills
- Ability to manage competing priorities and adapt to change
- Attention to detail
- Ability to successfully lead a global team
- Effective time management
- Good presentation skills
- Good business awareness and business development skills, including financial awareness
- Excellent communication skills
Benefits
Comp & perks- No benefits, perks, or compensation extras are specified in the posting.