Vice President, Biometrics
Description
Job Title: | Vice President, Biometrics |
Location: | Hybrid / Remote |
Position type: FLSA: | Full time Exempt |
Department: | Biometrics |
Strive to Bring a Profound Difference to our Patients
At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
The Opportunity
The Vice President, head of biometrics is the company’s foremost expert for biostatistics design, statistical software programming, analysis, quality control and reporting. This position will be responsible for biometric output delivery across Avidity’s clinical programs, as well as deciding on policies, data standards and standard procedures for the department. This position will work cross-functionally to design studies, collect, analyze, interpret and publish data. This position is accountable for accurate, clear, purposeful, consistent and audit-worthy data outputs for internal review and external dissemination.
What You Will Contribute
- Lead the biostatistics and programming team and set the strategy and resourcing for the department
- Accountable for statistical design proposals, study-level and integrated analysis for clinical programs
- Lead statistical expert for interaction with regulatory authorities and external scientific communication
- Accountable for high quality, impactful and timely biometric outputs
- Recruit, evaluate and manage team members and instill company values
- Technically guide junior staff
- Ensure effective collaboration and goal setting with colleagues in clinical development, data management, development sciences, medical affairs and other departments
- Oversee statistical analysis and data presentation sections of regulatory documents and license applications
- Ensure best practices to improve quality, efficiency and effectiveness in the department
- Ensure compliance with CDISC standards for eCTD submission
What We Seek
- Masters/doctorate in Statistics
- At least 15 years of biostatistics in the pharmaceutical/biotechnology industry, with line management experience
- Strategic thinker who will guide not only innovative endpoint evaluation strategies for the clinical trials but also the evolution of the department within a growing and multinational commercial organization
- Clear, effective communicator who explains biostatistics principles and makes strategic recommendations in an audience-appropriate way
- Demonstrable leadership experience with drug/biologic license applications with a track record of solving problems and effectively responding to regulatory questions
- Fluent in handling of imputation methods, measurements of secular change, longitudinal data integration and mixed models for repeated measures
- Extensive knowledge of the latest programming standards and data infrastructure
- An accountable player-manager who can balance leadership and resource organization with delivery to program goals
- Awareness of Artificial Intelligence initiatives in biometrics
- An innovator who can present the range of efficacy, PRO and safety data persuasively
- Experience with rare diseases is required
- Experience with management of CROs/biostatistics vendors is required
What We will Provide to You:
- The base salary range for this role is $315,000 – $352,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
- This role can be located remotely, though travel to company and meetings will be required.
- Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
- A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
Avidity Biosciences | 10578 Science Center Dr. Suite 125 | San Diego, CA | 92121 | O: 858-401-7900 | F: 858-401-7901 |