Vp/Director Biostatistics

POSITION SUMMARY

Vistagen Therapeutics, Inc. (Vistagen), is seeking a VP/Director level leader who will be responsible for managing statisticians, programmers, and consultants to support all statistical and programming needs for Vistagen programs from pre-IND through Commercialization. As a member of the Clinical Operations and Development team, the ideal candidate will play a key role in strategic planning for all Vistagen clinical programs and across all R&D functions. This will be a full-time remote position.

KEY DUTIES & RESPONSIBILITIES

• Provide strategic and statistical expertise in design of clinical development plans, clinical study protocols, analysis, and clinical study reports.

• Functional Representative in key internal facing senior meetings such as program teams, clinical development, operations, and regulatory affairs leadership team, portfolio steering team and management team, as well as more external facing meetings such as Board of Directors.

• Summarize and present statistical strategies and/or key study results to internal governance bodies, external collaborators including business partners and regulatory agencies.

• Plan and oversee deliverables and timeline of study readouts including regular data reviews, predefined interim analysis and final analysis to support decision making

• Work closely with clinical development, clinical operations, pharmacovigilance, clinical pharmacology, translational science, and medical writing to support clinical study planning and execution.

• Manage an existing team of statisticians and statistical programmers and support and foster their professional development needs and build the team as company progresses.

• Represent Biostatistics function in the program team and contribute to cross-functional decision making on study design, endpoint selection, data collection, and analysis strategies, ensuring alignment with study objectives.

• Perform sample size calculation for continuous, dichotomous, and time to event endpoints in various study design.

• Perform simulation studies to explore the statistical operating characteristics in study design phase including innovative/adaptive designs.

• Proactively identify and anticipate technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research, and approve and implement alternative analysis strategies or other recommendations to address these issues.

• Evaluate performance of patient enrichment biomarkers including metrics for AUC, PPV, NPV and determination of assay thresholds for use in prospective trials.

• Write the statistical section in clinical protocols.

• Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation.

• Develop exploratory statistical analysis plans for predictive and pharmacodynamic biomarkers and help develop companion diagnostics strategies for the program.

• Interpret study results and write (or at least QC and review) statistical summary reports of study results.

• Perform statistical analyses to support publications in medical conferences.

• Collaborate with data management team to support QC of CRO activities to include UAT, Query management, Data review, DM documentation such as DMP, DVS, edit checks, coding, lock process.

• Support development of eCRFs and be responsible for specs for IVRS, SDTM, and ADaM.

• Contribute to the implementation, maintenance, and evolution of the systems and processes involved in the collection, review and analysis of clinical and translational data.

• Responsible for statistical programming activities including the development of standard statistical documents such as TLFs, Programming specs (e.g. SDTM and ADaM), SAS macros, and SOPs.

• Develop proper resources and process regarding hardware, software, SOP and work instructions to provide effective support to clinical studies, and ascertain needs for potential program development of novel statistical methodology.

QUALIFICATIONS

• PhD or equivalent in Statistics or Biostatistics required

• 12+ years of experience in pharmaceutical development and applied statistics/statistical consulting required, experience in Central Nervous System (CNS) a plus.

• 7+ years of management experience leading biostatistics and programming groups

• Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred

• Knowledge of FDA, EMA, and ICH guidance for drug development pertaining to statistics

• Experience with the relevant regulatory requirements for data management and supporting SOPs

• Experience in use of commercial clinical data management systems/EDC products (e.g. RAVE, Inform, TrialMaster, etc)

• Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies

• Familiar with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions

REQUIRED COMPETENCIES:

• Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency

• Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators

• Enthusiastic, passionate about bringing important new therapies to patients with cancer, and willing to roll up their sleeves to do whatever it takes while building the right team of outstanding statistics and data management professionals.

• Effective communication skills and able to explain complex statistical approaches to non-statisticians.

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.

What we offer:

• Industry competitive compensation

• Performance-base 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 HSA

• Basic Life Insurance 2x Earnings & 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 & Observance of World Mental Health Day

• Winter shut-down

• 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 $230,000 to $280,000 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 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 the 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.

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. 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.

About Us:

Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen's pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D-aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression, and several other CNS disorders.

At Vistagen, we emphasize that mental health is foundational to living vibrant and healthy lives. We believe that healthy minds create healthy communities, and our core goal at Vistagen is to radically improve mental health and well-being worldwide - One Mind at a Time. We are change-makers committed to improving lives by developing innovative, science-based mental health care medicines with the potential to make the impossible, possible - to empower and support patients and their caregivers to achieve faster-acting efficacy without the side effects and safety concerns associated with current treatment options for anxiety and depression.

Vistagen Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.