Job Title:
Associate Director, Biostatistics
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
Biometrics
7575-2024-1-P
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 Associate Director (AD) of Biostatistics will support the program statistical lead and may lead one or more studies. The position will provide technical leadership and biostatistical support for clinical trial design, conduct, evaluation, and interpretation of study results. This position will also involve regulatory responses and filing activities; contributing to statistical analyses and preparing the submission data package.
Additionally, the position will be involved in department or cross-functional departmental standards, processes, training, and initiatives.
What You Will Contribute
- Review CRFs and other study documentation and draft statistical analysis plan (including ISS/ISE) and develop TFL shell and specification
- Manage CRO and oversee the execution of statistical analyses, review statistical outputs
- Create/review study randomization files and contribute to the protocol, IDMC charter, and study-related document authoring
- Present and interpret study results and author and review regulatory documents (including CSR) and publications.
- Work with the biometrics team to provide the data package relevant for submission or reimbursement.
- Provide input into product development strategy and decision-making (e.g. considerations for interim analyses, innovative designs, and comparisons with natural history studies or competitors, etc.)
- Contribute to research in advanced statistical methodologies
- Provide statistical support to cross-functional teams
- Contribute to developing department standards, procedures, and initiatives
What We Seek
Qualifications:
- Generally PhD in Biostatistics or Statistics with 8+ years (or MS with 10+ years) of relevant pharmaceutical experience
- Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
- Experienced in hands-on study-level work including authoring SAP, TFL specification, and validating outputs
- Knowledge of CDISC including SDTM, ADaM, and controlled terminologies
- Have a working knowledge of all appropriate relevant regulatory guidance documents (e.g. ICH, FDA, and EMEA)
- Experienced in NDA / BLA / MAA activities as a key contributor from a statistics perspective and direct involvement in regulatory interaction
- Ability to respond to regulator's inquiries for products undergoing registration and approved products
- Demonstrated organized, detail-oriented, and problem-solving skills and ability to prioritize and complete multiple tasks to meet the timeline. Flexible to adapt to change.
- Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.
- Familiar with SAS and other statistical software (i.e. R, Python, etc.)
Preferred:
- Experience in rare diseases
- Experience in statistical methods analyzing longitudinal data
- Advanced statistical knowledge in adaptive design, real-world data comparison, machine learning, and AI applications.
What We will Provide to You:
- The base salary range for this role is $188,300 – $208,200. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
- 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-###-####
F: 858-###-####