Director, Biostatistics (Remote)

Company Overview: 

Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.

We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression.

Vividion was ranked #2 mid-size company on The San Diego Union-Tribune's 2022 Top Workplaces list.

Job Summary: 

Reporting to the Chief Medical Officer, the Director, Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.

Essential Duties and responsibilities:

• Independently leads the development and execution of statistical aspects for multiple complex clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions, and publications.
• Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews study randomization, sample size/power estimations.
• Provides scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements in a clear, concise, complete, and transparent manner that provide influence on key development decisions.
• Develops statistical programs to perform pre-specified or ad-hoc analyses and prepare data displays.
• Provides leadership to the organization in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design.
• Review of SDTM and/or ADaM programming specifications. Review of vendor data transfer specifications for that data will be included in SDTM.
• Collaborate with cross functional peers to facilitate and optimize the product development and registration process to meet deliverables and timelines for statistical data analysis and reporting
• Manage biostatistics vendors, identify potential risks and resolve issues with CROs
• Takes accountability for ensuring quality in all planning, design, and execution of assignments associated with the assigned protocol or project.

Experience and education requirements:

• PhD in statistics or equivalent, with at least 10 years of relevant experience in biotechnology or pharmaceutical industry
• Demonstrated experience in providing statistical input and direction into the design of clinical studies
• Proficiency with statistical programming in SAS and/or R.
• Knowledgeable in CDISC standards, including SDTM, ADaM.
• Extensive knowledge of GCP, ICH guidelines, FDA regulations
• Preferably NDA experience, including eCTD submission.

Required Key Attributes: 

• Demonstrated leadership skills.
• Effective troubleshooting and problem-solving skills
• Excellent oral and written communication skills
• Be an effective team player and strong individual contributor, flexible, and able to handle multiple tasks and deliver high quality results under tight timelines

Further Information: 

In addition to a competitive compensation package with long-term incentives and 401k match, Vividion also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, and disability insurance.

Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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