Job Description:
We are seeking a highly motivated and qualified leader to join ADARx Pharmaceuticals as a Global Director of Biostatistics to lead statistical strategy and execution across clinical development programs. The successful candidate will provide statistical leadership through clinical development, regulatory submissions, and post-marketing activities. This role is ideal for an individual who thrives in a fast-paced, high-growth environment and is passionate about making a meaningful impact in drug development.
Essential Responsibilities:
* Provide statistical leadership in the design, analysis, and interpretation of clinical trials across all phases.
* Applies statistical principles and appropriate methodology to align with Health Authority guidelines and meet regulatory requirements. Ensures proper statistical approaches for design and analysis of clinical studies employed.
* Collaborate with cross-functional teams including Clinical Development, Data Management, Regulatory, and Medical.
* Develop statistical analysis plans (SAPs), study protocols, and clinical development strategies.
* Lead the development and review of tables, listings, and figures (TLFs), and ensure the quality and integrity of statistical deliverables.
* Oversee internal and external biostatistics teams, including CRO partners, ensuring compliance with regulatory standards (e.g., FDA, EMA, ICH). Evaluates and manages CRO for applicable scope, timelines and deliverables.
* Support regulatory submissions, including preparation of briefing documents, responses to questions, and representation at agency meetings.
* Mentor and develop junior biostatisticians; contribute to building biostatistics capabilities and infrastructure within the company.
* Stay current with regulatory guidance, industry trends, and methodological innovations relevant to biostatistics and clinical development.
* Creates, maintains, and implements SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, and efficiency.
Essential Physical Characteristics:
Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.
On-Site Protocol:
Physical presence at the ADARx Pharmaceuticals worksite is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
Qualifications:
* Ph.D. or Master's degree in Biostatistics, Statistics, or a related discipline.
* Ph.D. with 8+ years, or Master's with 12+ years of experience in the biopharmaceutical industry.
* Proven experience in the statistical design and analysis of clinical trials, preferably in in multiple disease areas and RNA therapeutics.
* Demonstrated success in working on INDs, NDAs/BLAs, or similar regulatory submissions.
* Strong knowledge of statistical methodologies and regulatory requirements.
* Proficiency in SAS programming; knowledge of R is a plus.
* Excellent communication skills with the ability to clearly explain statistical concepts to non-statisticians.
* Leadership experience, with the ability to manage teams and external collaborators effectively.
* Passion for science, innovation, and collaboration.
Required Key Attributes:
* Must be able to work independently with supervision as needed.
* Must be collaborative, work well with other Clinical Development team members in a matrix team environment.
* Excellent written and verbal communication skills are essential for this role.
* Strong organizational skills with attention to detail and accuracy.
* Ability to maintain a high level of confidentiality and exercise discretion.
* Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges.
* Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders.
Compensation:
* This is a full-time position, Monday-Friday.
* Pay is commensurate with experience.
* Equity-based compensation
* Performance-based bonuses
* 401(k) with Company Match
* Medical, Dental, Vision
* Flexible Spending Account
* Life Insurance
* Employee Assistance Program
* Employee Discounts
* Gym Membership
* Paid Vacation
* Paid Holidays
* Paid Sick, Jury Duty, Bereavement
Work Authorization:
* United States (Required)
* Background Check
* As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.
Company Overview:
ADARx Pharmaceuticals, Inc., (the "Company" or "ADARx") located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.
ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors.
ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Disclosure Statement
* The above statements are intended to describe the general nature and level of work being 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 employees assigned to this position.
* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
* The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
* Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
* Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.