Job Details

Profoundly Improve Peoples lives by Revolutionizing the Delivery of RNA Therapeutics

At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving peoples 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.

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).

The Opportunity

We are looking for a Senior Manager, Biostatistics to provide technical leadership and biostatistical support for designing, conducting, evaluating, and interpreting study results in clinical trials. This person will report to the Senior Director of Biostatistics and will assist the statistical program lead as well as oversee one or more studies.

What You Will Contribute

• Review CRFs and other study documentation, and draft statistical analysis plan (SAP) 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 the statistical section for CSR and publications.
• Supporting the program lead to provide a regulatory response and the data package relevant for submission or reimbursement.
• Provide statistical input into product development strategy and decision-making
• 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

• PhD in Biostatistics or Statistics with 5+ years (or Masters Degree with 7+ years) of relevant pharmaceutical experience required and experience in rare diseases is preferred.
• Strong background and working knowledge of statistical methods that apply to 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).
• Demonstrated organized, detail-oriented, and problem-solving skills and ability to prioritize and complete multiple tasks to meet the timeline.
• Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.
• Familiarity with SAS and other statistical software (i.e. R, Python, etc.).
• Experience in statistical methods analyzing longitudinal data and advanced statistical knowledge in adaptive design, real-world data comparison, machine learning, and AI applications is preferred

What We Will Provide To You

• The base salary range for this role is $171,000 - $189,000. 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 include the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match.
• 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 is an Equal Opportunity Employer and welcomes applications from diverse candidates.