Director, Biostatistics

This role will provide statistical leadership to support compounds in the stages of clinical development, regulatory filing, or commercialization. Reporting to VP, Head of Biometrics, this person will serve as the lead biostatistician for a number of clinical trials with the primary responsibilities of statistical design, data analysis from planning to execution, and results interpretation and dissemination. This position will also take part in the potential regulatory filing to serve as the lead biostatistician for integrated data analysis. 

The Director, Biostatistics will be hands-on and provide strategic and statistical input as one of the SMEs as an integral part of multi-functional project teams. This role holds the primary responsibilities to ensure the deliverables by statistical vendor(s) are of high quality and meet timeline. This person will also work closely with Neumora's Statistical Programming group to perform statistical analyses using internal resources as needed and will partner with Clinical Data Management colleagues to support data cleaning activities.

Responsibilities:

• Participate in the discussion and contribute to the creation of clinical development plan 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 support 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 at the timely manner.
• Hold the primary responsibilities of managing statistical vendor(s) to deliver other data analyses as needed during the conduct of the trial (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.
• Contributes to the Biometrics SOPs development.

Qualifications:

• 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 records of using statistical methods to solve real world problems and support compound’s advancement.
• Rich experience in study SAP and TLF shells development.
• Experience in working with statistical vendors to implement the SAP and deliver with quality and speed.
• Solid knowledge in SAS or R statistical computational language.
• Working knowledge of regulatory guidance relevant to clinical trials from design to analysis.
• Demonstrated capacity of collaborating 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 capacity of problem solving and interests of continued leaning.
• Strong organizational skills, project management skills, and time management skills.
• Detail-oriented and hold high standards of excellence for own work product.
• Deliver and communicate effectively in the work-from-home environment.
• Excellent interpersonal skills and a good team player.

2024 Company benefits include:

• 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- 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: $222,388-$235,000