Remote Director Biostatistics

Summary

Join our team at Neumora as we revolutionize the way patients with brain disease are treated. We're seeking a Director, Biostatistics to provide statistical leadership and support compounds in clinical development, regulatory filing, or commercialization.

Requirements

• A PhD degree in statistics or biostatistics with at least 10 years’ experience in clinical trial design, analysis and reporting
• Solid statistical knowledge and experience in clinical trial design (early or late phase)
• Proven record of using statistical methods to solve real world problems and support a compound’s advancement
• Rich experience in study SAP and TLF shells development
• Experience working with statistical vendors to implement the SAP and deliver with quality and speed
• Solid knowledge of SAS or R statistical computational language
• Working knowledge of regulatory guidance relevant to clinical trials from design to analysis
• Demonstrated ability to collaborate with Clinical Development, Clinical Operations, Regulatory Affairs and other relevant functions to deliver common goals
• Experience in integrated data analysis and NDA/BLA/MAA filing
• Demonstrated problem-solving ability and interest in continued learning
• Strong organizational skills, project management skills, and time management skills
• Detail-oriented and holds high standards of excellence for own work product
• Ability to deliver and communicate effectively in the work-from-home environment
• Excellent interpersonal skills and a good team player

Responsibilities

• Participate in the discussion and contribute to the creation of clinical development plans for the assigned compound(s)
• Collaborate with cross-functional experts on clinical trial designs from objectives to sample size
• Contribute to protocol development including authoring statistical methods section and reviewing the protocol throughout
• Ensure the accuracy of randomization schedule and contribute to eCRF design such that data collection closely supports trial design intent
• Develop and finalize study Statistical Analysis Plan (SAP) and the related shells for table/listing/figure (TLF)
• Hold the primary responsibilities of managing statistical vendor(s) to implement SAP and deliver study results of high quality in a timely manner
• Hold the primary responsibilities of managing statistical vendor(s) to deliver other data analyses, as needed, while the trial is being conducted (e.g., DMC support, or interim analysis)
• Contribute to any forms of data dissemination, including clinical study reports, regulatory documents, and publications
• Develop SAP and related shells for TLFs for integrated data analysis, as needed; work with statistical vendor(s) to implement the SAP and deliver the results for integrated data analysis
• As an important player in the potential regulatory filing preparation team, contribute to the dossier creation and review
• Write own SAS programs when necessary for the purpose of analysis or validation
• Contribute to Biometrics SOPs development

Benefits

• Medical, dental, vision, and life insurance
• 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• Company Equity (New Hire Awards, Annual Awards, ESPP)
• Annual paid time off
• Accrued Vacation Days: 15 days per year
• Sick Days: 10 days per year
• Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
• Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
• Discretionary year-end bonus