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Tech Stack
Tools & technologiesGoogle Cloud Platform
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.
- Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy.
- Conducts all appropriate validation requirements, according to Standard Operating Procedures (SOPs), for each task undertaken.
- Checks programming logs for cleanliness and correct processing of data.
- Inputs into Data Issues log and follows issues to appropriate resolution.
- Perform statistical team lead role on single studies.
- Works closely with the Project Team Lead and supervisor to deliver on time, with high quality and within budget.
- Build and maintain effective customer relationships, driving statistical discussions, providing support and/or guidance for statistical activities.
- Acts as a lead in meetings, documenting where necessary and following up on actions.
- Actively participates in internal project team meetings.
- Plans and documents timelines, forecasts resource needs, suggests work that may be out of scope.
- Shares accountability for the financial success of assigned studies.
- Identifies risks to project delivery and/or quality and proposes solutions to mitigate risks.
Requirements
What you’ll need- Bachelor's Degree Biostatistics or related field and 1 - 3 years relevant experience Req
- Master's Degree Biostatistics or related field and 1-3 years relevant experience Req
- Ph.D. Biostatistics or related field Req
- Typically requires 1-3 years of prior relevant experience, or equivalent combination of education, training and experience.
- Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.
- 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, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
- Strong individual initiative.
- Strong organizing skills.
- Strong working knowledge of SAS computing package.
- Familiarity with other relevant statistical computing packages such as StatXact.
- Ability to effectively manage multiple tasks and projects.
- Ability to provide and accept direction of 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 Clinical Data Interchange Standards Consortium (CDISC)/ADaM).
Benefits
Comp & perks- Training, guidance and mentorship to lower level and new staff.
- Provides timely progress updates.
- Helps train staff regarding operational items.
- Strong commitment to quality.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
biostatisticsstatistical methodsdata analysisstatistical programmingSASStatXactdata validationproject managementclinical trial analysisfinancial analysis
Soft Skills
communication skillsattention to detailorganizational skillsproblem-solvinginitiativeteam leadershiprelationship buildingtime managementdocumentationrisk identification
Certifications
Bachelor's Degree in BiostatisticsMaster's Degree in BiostatisticsPh.D. in BiostatisticsGood Clinical Practice (GCP)International Conference on Harmonization (ICH) guidelines
