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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 and clinical trial conduct, with proficiency in SAS and a strong understanding of clinical data structures, including CDISC standards. Capable of leading programming teams, managing project timelines and budgets, and ensuring compliance with regulatory requirements.
Highest-signal resume keywords
SAS ProficiencyClinical/Statistical Programming ExperienceProject Management SkillsKnowledge of CDISC StandardsAnalytical Programming
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 ProgrammingData AnalysisQC of DatasetsADaMSDTMData Definition TableE-SubmissionRelational DatabasesProgramming TechniquesStatistical Analysis Plans
Soft Skills
Analytical SkillsTeam CollaborationBusiness AwarenessProblem SolvingCommunication Skills
Tools & Technologies
MS OfficeXMLPinnacle 21EDCTracking Spreadsheets
Industry Keywords
Clinical TrialsPharmaceutical DevelopmentICH-GCPRegulatory ComplianceStatistical Programming Lead
About the role
Key responsibilities & impact- Provide technical expertise for the conduct of clinical trials
- Act as an internal subject matter expert, providing technical support and expert advice
- Work independently on programming activities related to clinical study data analysis and reporting
- 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 and create global programs, tracking spreadsheets, and required documentation
- Review statistical analysis plans, mock shells, and database set-up specifications
- Interact with sponsors and internal stakeholders on statistical programming issues
- Assist project teams in resolving daily work problems
- Use efficient programming techniques to produce and QC derived datasets, including SDTM and ADaM/TLF, tables, figures, and data listings
- Produce and QC dataset specifications, process-supporting documents, and submission documentation
- Ensure QC of derived datasets, tables, listings, and figures complies with corporate quality standards, SOPs/guidelines, ICH-GCP, and international regulatory requirements
Requirements
What you’ll need- Proficiency in SAS
- Minimum 3 years of clinical/statistical programming experience within pharmaceutical clinical development
- Experience handling and processing upstream data, including multiple data forms, workflow, eDC, and SDTM
- Experience producing outputs for downstream requirements, including ADaM, Data Definition Table, and e-submission
- Proficiency in analytical programming
- Excellent analytical skills
- In-depth understanding of clinical data structures, including CDISC standards, and relational databases
- Proficiency with MS Office, XML, and Pinnacle 21
- Ability to work in a team environment with clinical team members
- Strong project management skills
- Good business awareness and business development skills, including financial awareness
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required
- Competent written and oral English
- Must be authorized to work in South Africa
- Employment visa sponsorship is unavailable
Benefits
Comp & perks- Competitive financial packages
- Training and development
- Fully flexible work arrangement
- Fully home based work option
- Office access for employees who live close to the office
- Healthy work/life balance
- Employee welfare support