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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive programming expertise in SAS, R, and Python, with a strong focus on developing and validating analysis packages in compliance with CDISC standards. Proven ability to lead programming activities for clinical trials while mentoring junior programmers and collaborating with cross-functional teams in a regulated environment.
Highest-signal resume keywords
5+ Years Programming ExperienceSAS ProgrammingR ProgrammingCDISC Standards ExpertiseOncology Therapeutic Area Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Programming in SASProgramming in RProgramming in PythonDeveloping Analysis PackagesValidating Custom ProgramsApplying Quality Control ProceduresRegulatory Requirements ComplianceAI/ML Tools ApplicationClinical Trials SupportStatistical Analysis
Soft Skills
Mentoring Junior ProgrammersCollaboration Across TeamsContinuous ImprovementNetworking and Relationship BuildingProblem-Solving
Industry Keywords
Good Programming PracticesCDISC StandardsRegulated EnvironmentClinical Development ProgramsOncology Therapeutic AreaEMA Regulatory InteractionsFDA Regulatory InteractionsAgile MethodologyGovernance FrameworksRisk Mitigation
Tech Stack
Tools & technologiesPython
About the role
Key responsibilities & impact- Independently lead programming activities for one or more studies
- Develop, maintain, and validate complex analysis packages
- Ensure programming activities adhere to Good Programming Practices and CDISC standards
- Mentor junior programmers in technical programming tasks and industry best practices
- Lead programming support for regulatory interactions, including EMA and FDA
- Identify gaps and inefficiencies and recommend and implement innovative solutions
- Establish and uphold governance frameworks
- Identify risks early, devise mitigation plans, and ensure timely escalation
- Collaborate with clinical, statistical, and operational stakeholders in an agile, squad-based environment
- Bridge scientific requirements with technical solutions to support clinical development programmes
Requirements
What you’ll need- 5+ years of programming experience within the pharmaceutical, biotechnology, healthcare, or other regulated industry
- Experience programming in SAS, R, Python, or a comparable programming language
- Experience supporting clinical trials, clinical development programs, or analysis of clinical research data
- Experience developing, validating, and maintaining custom programs, analyses, tables, figures, or listings
- Experience applying programming standards, quality control procedures, and regulatory requirements within a regulated environment
- Expertise in Oncology therapeutic area specific requirements like RECIST1.1
- Experience collaborating with cross-functional stakeholders
- Experience guiding others in the use of AI/ML tools or applying these tools to improve efficiency
- Experience contributing to internal technical discussions, forums, or external technical organizations
- Experience contributing to department strategies and key technical initiatives
- Demonstrated networking and collaboration across departments, divisions, and external partners
- Experience facilitating integration across matrix teams and contributing to planning and execution of programming activities
- Experience guiding teams and individuals, fostering continuous improvement, collaboration, and innovation
- Strong expertise in CDISC standards and its application
- Demonstrated proficiency in R
Benefits
Comp & perks- Competitive salary
- Annual bonus based on company performance
- Healthcare and wellbeing programmes
- Pension plan membership
- Shares and savings programme
- Hybrid working model with remote and in-office work
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave
- Comprehensive benefits program for US employees
