Associate Director, Biostatistics
Definium Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $183,656 - $208,950 per year
Job Level
About the role
- Serve as Study Biostatistician for assigned clinical trials to provide statistical support from design, analysis to reporting
- Serve as the biostatistician conducting integrated data analyses to support regulatory filing dossier preparation
- Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objectives, endpoints and sample size
- Author statistical methods section in the protocol and review the protocol throughout
- Make certain the accuracy of randomization algorithm and contribute to eCRF design to ensure that study objectives, data analysis and data collection are aligned
- Work with statistical vendors and internal Statistical Programming team to deliver study results or integrated analyses with quality and speed
- Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication
- Conduct data analyses as needed by using own SAS programs in collaboration with internal Statistical Programming team
Requirements
- A PhD degree in Statistics, Biostatistics or relevant fields with at least 7 years’ working experience, or a Master’s degree in Statistics, Biostatistics or relevant fields with at least 10 years’ working experience, in pharmaceutical or biotechnology companies
- Solid statistical knowledge and experience in clinical trial design (early to late phase), data analysis, and reporting
- Rich experience in authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions
- Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed
- Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis
- Working knowledge of regulatory guidance relevant to clinical trials from design to analysis
- Demonstrated capacity of collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science and other relevant functions to deliver common goals
- Strong organizational and project management skills; demonstrated interest in continued learning and growing
- Detail-oriented and hold high standards of excellence for their work products
- Deliver and communicate effectively in the work-from-home environment
- Excellent interpersonal skills and is a good team player
Benefits
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
biostatisticsclinical trial designdata analysisstatistical programmingSASstatistical methodsrandomization algorithmSAP authoringTFL shellsdata reporting
Soft Skills
collaborationorganizational skillsproject managementdetail-orientedcommunicationinterpersonal skillsteam playerproblem-solvingadaptabilitycontinuous learning
Certifications
PhD in StatisticsPhD in BiostatisticsMaster's degree in StatisticsMaster's degree in Biostatistics