Senior Manager, Biostatistics

Avidity BiosciencesUnited States

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Job Title :

Senior Manager, Biostatistics

Location : Remote

Position type : FLSA :

Full time

Exempt

Department : Finance ID :

Biometrics

2301-Q125-2

Profoundly Improve People’s 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 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

We are looking for a Senior Manager 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. This role also includes working on regulatory responses and filing activities, contributing to statistical analysis, and preparing submission packages. Additionally, the individual will be involved in the statistics 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 (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 (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

PhD in Biostatistics or Statistics with 5+ years (or Master’s 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. Flexible to adapt to change.

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. 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.

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Senior Manager • United States