Director, Statistical Programming

Position Overview:

We are seeking a highly skilled, dynamic, and innovative Director of Statistical Programming with expertise in statistical programming and data analysis to support clinical development and research initiatives. This individual will lead efforts in reviewing and interpreting data for trends, anomalies, and quality issues, while overseeing the creation and delivery of reports and data extracts to support internal and external activities. The candidate must have expertise in state-of-the-art data processing and statistical analyses. The ideal candidate will have extensive experience in SAS and R programming, advanced Excel skills, and a strong foundation in data analysis and reporting. The candidate must be a strong team player with the ability to work effectively across cross-functional teams, fostering collaboration and driving alignment toward shared goals.

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to VP, Biostatistics.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

• Develop, validate, and maintain programs for data cleaning, analysis, and reporting using SAS and R.
• Generate and validate SDTM and ADaM datasets, Define.xml files, and associated documentation in compliance with CDISC standards.
• Oversee the creation of analysis datasets, tables, listings, figures, for clinical study reports, and publications.
• Act as programming lead for regulatory deliverables, ensuring alignment with ICH, FDA, EMA guidance, and internal pertinent processes and standard operating procedures.
• Collaborate cross-functionally with Biostatistics, Clinical R&D, Regulatory Affairs, and Data Management to support study design, data analyses, and reporting plans.
• Review and contribute to statistical analysis plans (SAPs), case report forms (CRFs), database specifications, validation plans, and programming specifications.
• Provide oversight and direction to external vendors (e.g., CROs), ensuring deliverables meet quality and timeline expectations.
• Interpret clinical data to identify trends, inconsistencies, and quality issues, and provide actionable insights to cross-functional teams.
• Contribute to the development and maintenance of programming SOPs, work practices, and technical standards.
• Support audits and inspections by providing programming documentation and subject matter expertise.

Qualifications:

• PhD in Statistics or Biostatistics
• Minimum of 8 years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry.
• Proven expertise in SAS and R programming; proficiency in advanced Excel functions and data visualization tools.
• Strong understanding of clinical trial design, data standards (e.g., CDISC SDTM/ADaM), and regulatory requirements.
• Demonstrated ability to lead cross-functional teams and manage complex projects.
• Excellent analytical, problem-solving, and communication skills.
• Experience with data quality assurance and validation processes.
• Ability to work in a fast-paced, dynamic environment with shifting priorities.

Compensation and Benefits

What we offer:

• Industry competitive compensation
• Performance-based bonuses
• Stock options
• Employee Stock Purchase Plan
• 401k plan
• A collaborative and innovative work environment at the forefront of biotech advancements

Give your best, live wholesomely:

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HAS
• Basic Life Insurance 2x Earnings and AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-life balance:

• Unlimited paid time off
• Flexible work schedule
• Remote work option
• Paid holidays
• Mental health days
• Winter shutdown
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $215,000-$240,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally.

Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

All Employee’s have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA)

OVERVIEW OF THE COMPANY

Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.vistagen.com.