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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical analysis and programming, with a strong focus on biostatistics and clinical research methodologies. Capable of leading projects, mentoring staff, and ensuring compliance with regulatory standards while maintaining high-quality deliverables.
Highest-signal resume keywords
Statistical Analysis PlansSAS Computing PackageGood Clinical Practice (GCP)International Conference on Harmonization (ICH)CDISC/ADaM Data Standards
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 AnalysisProgramming SpecificationsData ValidationSample Size CalculationsStatistical ReportingDatabase DesignStatistical MethodsData Issue ResolutionBudget ManagementQuality Control
Soft Skills
Excellent Communication SkillsAttention to DetailStrong Organizational SkillsProblem-Solving AbilityInitiative
Tools & Technologies
StatXactStatistical Computing Packages
Industry Keywords
Clinical ResearchBiostatisticsRegulatory RequirementsClinical TrialsProject Management
About the role
Key responsibilities & impact- Prepare analysis plans and write detailed specifications for analysis files, tables, listings, and figures
- Interpret analyses and write statistical sections of study reports
- Provide training, guidance, and mentorship to lower-level and new staff
- Complete and review complex assigned tasks accurately and conduct validation according to SOPs
- Check programming logs, document data issues, and follow issues through resolution
- Perform statistical team lead responsibilities on single studies when assigned
- Collaborate with Project Team Leads and supervisors to deliver work on time, with quality, and within budget
- Build and maintain customer relationships and support statistical discussions and activities
- Lead meetings, document actions, provide progress updates, and contribute to estimate-at-completion reporting
- Review and advise on database design, validation checks, critical data, and data issue resolution
- Handle database lock and unblinding processes with appropriate supervision
- Author or quality-control statistical analysis plans and shells
- Write and maintain programming specifications and program datasets to industry standards
- Program tables, listings, and figures; check output format and content and ensure consistency
- Plan timelines, forecast resource needs, and identify out-of-scope work
- Support study financial accountability, cost control, revenue recognition, and budget expectations
- Train and mentor staff and support knowledge sharing
- Identify project risks and propose mitigation solutions
- Assist with protocol development, sample size calculations, protocol review, and case report form review
- Author or quality-control statistical sections of protocols
- Review and comment on study-level proposals and budgets; contribute to RFPs and bid defenses
- Review or draft clinical study reports and statistical reports
- Serve as a customer point of contact and consult clients on operational topics
- Draft or review randomization specifications and schedules and potentially serve as unblinded lead statistician
- Assist with cross-functional collaboration and other ad hoc responsibilities
Requirements
What you’ll need- Bachelor's Degree Biostatistics or related field and 1 - 3 years relevant experience required, or Master's Degree Biostatistics or related field and 1-3 years relevant experience required, or Ph.D. Biostatistics or related field required
- Typically requires 1-3 years of prior relevant experience, or equivalent combination of education, training and experience
- Intermediate level knowledge of principles, theories, and concepts of a job area
- Excellent written and oral communication skills, including grammatical/technical writing skills
- Excellent attention and accuracy with details
- In-depth knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Familiarity with moderately complex statistical methods applicable to clinical trials
- Strong individual initiative
- Strong organizing skills
- Strong working knowledge of SAS computing package
- Familiarity with relevant statistical computing packages such as StatXact
- Strong commitment to quality
- Ability to effectively manage multiple tasks and projects
- Ability to provide and accept direction from lead team members
- Ability to solve moderately complex problems
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Working knowledge of relevant data standards such as CDISC/ADaM