At Avidity Biosciences, we are passionate about the impact of every employee in bringing potentially life-changing therapeutics to patients in need. Avidity is pioneering a new class of oligonucleotide-based therapies called AOCs, designed to overcome the current limitations of oligonucleotide therapies to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop transformative therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. If you are a committed, solution-oriented thinker, come make a difference with us.
Avidity Biosciences is looking for an experienced Biostatistician who is proactive and a self-starter with advanced technical and communication skills.
Reporting to the Vice President, Development Strategy and Biometrics, the candidate acts as program/therapeutic area* statistical lead:
- Provides technical leadership and biostatistical support on the design and conduct of clinical studies and endpoint selections/validation.
- Performs statistical analyses and participates in the evaluation, interpretation, and reporting of study results, and in regulatory submissions to the global regulatory agencies.
- Partners with cross functional teams throughout the drug development lifecycle and provides strategic input to optimize probability of success.
The candidate coordinates the effort across programs/therapeutic areas to identify, develop and implement departmental standards, applications, processes and training. The candidate provides timely support to the project teams on all statistical matters according to the project strategies and is responsible for addressing all administrative functions required for project management and milestones, identifying and communicating changes in project requirements that may affect key deliverables at the project level.
Essential Duties and Responsibilities
- Lead in product level activities including regulatory interactions and filing, and contribute strategically to the supporting programs from statistics perspective through the lifecycle of the drug development process
- Contribute in study level tasks including but not limit to: study design and sample size determination; author/review statistics section in the protocol, SAP and DMC charter; create/review study randomization files; develop TFL shell and specification; review CRFs and other study documentations; active participation in study related meetings
- Works collaboratively within biometrics teams and with cross functional teams to meet product deliverables and timelines for statistical data analysis and reporting
- Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
- Independently conduct analyses suggested by the data; propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
- Contribute in developing standards and research in advanced statistical methodologies
- Author/review regulatory documents or scientific publications
- Recruit and mentor junior team members
- Manage biometrics vendors
- PhD in Statistics or Biostatistics with a minimum of 8 / 10* years (min 11 / 13* years for master) of post-graduate experience in the clinical trials setting in the pharmaceutical industry
- Experience in rare diseases and/or neuromuscular diseases, development and validation of biomarker, PROs and clinical outcomes and in natural history studies are preferred
- Experienced in NDA / BLA / MAA activities as a key contributor from statistics perspective and direct involvement in regulatory interaction
- Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
- Experienced as product/therapeutic area* lead statistician and contribute in strategy discussion in cross functional settings
- Experienced in study level work including authoring SAP and TFL specification
- Solid understanding of mathematical and statistical principles; Experience in statistical methods analyzing longitudinal data is preferred
- Detailed-oriented with organization, problem solving and prioritization skills; demonstrated the ability to prioritize and complete multiple tasks according to company timeline
- Familiar with SAS and R; preferably with knowledge in CDISC including SDTM, ADaM, and controlled terminologies
- Excellent oral and written communication skills, with the ability to translate the clinical context into statistical considerations