Senior Enterprise Systems Analyst, SAP EWM and Logistics
Carrier
Associate Director, Biostatistics
MindMed
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $184,662 - $204,672 per year
Job Level
Senior
About the role
- Serve as Study Biostatistician for assigned clinical trials to provide statistical support from design, analysis to reporting
- 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
- Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP
- Hold the primary responsibility of working with statistical vendors and internal Statistical Programming team to deliver study results with quality and speed
- Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis)
- 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 interests of continued learning and growing
- Detail-oriented and hold high standards of excellence for own work products
- Deliver and communicate effectively in the work-from-home environment
- Excellent interpersonal skills and is a good team player
