Director of Biostatistics

Neumora was listed as #1 on BioSpace’s NextGen Bio “Class of 2023,” top life sciences startups to watch!

This position will provide statistical leadership in one or more therapeutic areas, including oversight of (pre-) clinical development strategy and implementation. Reporting to the Head of Biometrics, this position will also provide guidance to data management and statistical programming in data collection and analysis to support clinical programs, participate in the SOP development, as well as oversee the activities of CRO biostatistics teams to ensure deliverables are met with quality.

Responsibilities:

• Represents Biometrics on the Clinical Development Study/Program Team
• Participates in the development of the clinical development strategy and plan
• Collaborates with cross-functional experts on innovative trial designs
• Provides technical leadership in the design and execution of (pre-) clinical trials and statistical analysis plans
• Acts as the primary point-of-contact for questions to Biostatistics regarding (pre-) clinical studies
• Generates and/or verifies sample size calculations and randomization schedules as needed
• Writes statistical sections of the clinical trial protocols
• Collaborates with Data Management on the design of eCRFs and database requirements
• Contributes to clinical study reports and regulatory documents
• Supports medical publications
• Supports regulatory briefing book, meetings and interactions
• Performs quality control checks of statistical analyses and SAS programs as needed
• Contributes to the Biometrics SOPs development
• Oversees CROs for statistical support
• Supports and manages regulatory compliant Clinical Data Repository and biometrics analysis programming environment
• Participates in other activities and meetings to support Biometrics as necessary

Qualifications:

• A PhD degree in statistics or biostatistics with at least 8 years’ experience in clinical trials or a Master’s degree in statistics or biostatistics with at least 10 years' experience
• Excellent interpersonal skills and good conflict management and negotiation skills
• A good team player
• Demonstrated ability to communicate complex statistical concepts to non-statisticians
• Experience working on all phases of clinical studies
• Experience working on NDA/BLA/MAA development and submissions

Company benefits include:

• Medical, dental, vision, and life insurance
• 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• New hire stock options
• Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
• Leave of Absence: Paid family leave, paid short- and long-term disability
• Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $210,932- $224,075

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