Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Clinical Research Scientist plays a critical role in Clinical Development supporting clinical research programs including data collection and analysis, data management, and preparation of Clinical Study Reports (CSRs). This position is responsible for ensuring high-quality data is collected and managed in alignment with regulatory standards, and for contributing to the scientific analysis and interpretation of study results. • Collaborates closely with cross-functional teams, including clinical operations, regulatory, biostatistics, and medical writing, to ensure successful and compliant execution of clinical trials. • Supports leadership teams in special projects supporting business development. • Contributes to protocol synopses, clinical development plans, and evidence strategies that align endpoints with patient-relevant outcomes and regulatory expectations. Qualifications • Advanced degree in life sciences, pharmacy, or a related field (e.g., PharmD, PhD, NP, or master’s in clinical research). • 3+ years of experience in clinical research or a related field. Experience in a sponsor or biotech environment preferred; rare disease experience is a plus. • Proficient in tools to evaluate and present data including Word, Excel and PowerPoint. • Solid understanding of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidance, including E6 Revision 3 and E9, as well as familiarity with Title 21 of the Code of Federal Regulations (CFR) Part 11 and General Data Protection Regulation (GDPR) requirements for clinical data. • Ability to interpret Statistical Analysis Plans (SAPs) and tables, listings, and figures (TLF) templates, and work effectively with statisticians and programmers. Requirements • Strong knowledge of data collection and management practices. • Demonstrated CRF design and edit check specification experience. • Familiarity with Clinical Study Report (CSR) templates, guidelines, and regulatory requirements. • Strong analytical and organizational skills, attention to detail and commitment to data integrity. • Comfort communicating complex results to technical and non-technical audiences. • Ability to work collaboratively across multiple functions and manage complex projects. • Prior experience in endocrinology. Experience with pediatric populations, growth endpoints, or hormone biomarker strategies is a plus. Benefits • Industry-competitive compensation • Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life insurance. • Lumos covers 95 – 85% of medical premium • Health Reimbursement Arrangement • 8 weeks of fully paid parental leave for all new parents • Gym or fitness class reimbursement • 401(k) with 5% employer contribution • Flexible work hours and location • Generous PTO policy • 11 paid holidays in the US • Offices in Austin, TX and Ames, IA Apply tot his job