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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 clinical study support, with a strong focus on protocol development, statistical analysis plans, and regulatory submissions. Proficient in SAS programming and familiar with CDISC requirements, ensuring high-quality outputs and effective communication with diverse teams.
Highest-signal resume keywords
Master’s Degree In Statistics3+ Years Supporting Clinical TrialsSAS Programming SkillsCDISC Requirements ImplementationSample Size Calculation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Statistical AnalysisStatistical Analysis Plans (SAPs)Sample Size CalculationClinical Study Reports PreparationADaM Specifications GenerationEfficacy/Safety TablesData Review GuidelinesStatistical Results InterpretationExploratory AnalysesProtocol Development
Soft Skills
Effective CommunicationRelationship BuildingTeam Motivation
Tools & Technologies
SASR Programming
Industry Keywords
Clinical StudiesPharmaceutical IndustryBiotechnology IndustryCRO ExperienceRegulatory Submissions
About the role
Key responsibilities & impact- Support Phase I-IV clinical studies
- Perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions
- Provide statistical support to clinical studies
- Participate in study protocol development, study design discussions, and sample size calculations
- Review CRFs and data review guidelines
- Develop statistical analysis plans (SAPs), including analysis dataset and TLG specifications
- Perform statistical analyses and interpret statistical results
- Prepare clinical study reports, including integrated summaries for submissions
- Present and explain methodology and the consequences of decisions
- Work fully embedded within and dedicated to a global pharmaceutical client while supported by Cytel
- Collaborate with clinical, regulatory, programming, internal, and external teams
Requirements
What you’ll need- Master’s degree in statistics or a related discipline
- 3+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry
- Experience working for a CRO is strongly desired
- Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers
- Solid understanding and implementation of CDISC requirements for regulatory submissions
- Adept in ADaM specifications generation and QC of datasets
- Ability to build strong external and internal relationships and motivate a regional or global team
- Effective communication skills; able to explain methodology and consequences of decisions in lay terms
- Knowledge of R programming is a plus
- Regulatory work experience is a bonus
Benefits
Comp & perks- Consistent training, development and support
- Significant professional growth
- Professional development opportunities