Associate Director, Statistical Programming

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 2023 Top Workplaces list.

Job Summary:

The Associate Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. The incumbent is responsible for leading all the programming aspect of the project for all programming deliverables and participates in the identification and implementation of programming standards and macros to facilitate the creation of statistical deliverables. This position reports to the Director, Biostatistics and Statistical Programming, working closely with Biostatistics, Data Management, Clinical Operations, Regulatory, and other related disciplines, as well as CROs. This position can be fully remote.

Essential Duties and responsibilities:

• Provides comprehensive programming leadership and support to clinical project teams including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices.
• Oversees CRO SAS programming by providing ongoing review of activities and progress to ensure projects are delivered by the CROs on time with suitable quality.
• Oversees CRO effort related to derive data sets, programs, and analysis data set specifications. Oversee the CRO development of SAS programs for the creation of SDTM and ADaM data sets following CDISC standards for clinical trials. Oversee the CRO development of SAS programs for the creation of Tables, Listings and Figures for clinical trials.
• Leads Statistical Programming activities across multiple studies (or across a compound) and related oversight activities ensuring quality and timeliness.
• Leads / Supports the electronic submission preparation and review.
• Reviews key planning documents (e.g., statistical analysis plan, mock shells, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; assesses document robustness and impact on programming activities.
• Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards.
• Develops unambiguous and robust programming specifications (e.g. ADaM specifications)
• Demonstrates advanced knowledge of CDISC standards, medical terminology, clinical trial methodologies, and FDA/ICH regulations.
• Communicates proactively and effectively around issues and risks and contributes to its remediation.
• Identifies, leads, and supports opportunities to enhance processes and technology.

Experience and education requirements:

• Bachelor’s or MS degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 8 years programming experience in industry including support of significant regulatory filings.
• Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data.
• Broad expertise in Statistical Programming and in developing computing strategies.
• In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases.
• Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)
• Demonstrated ability processing upstream data (e.g. multiple data forms, workflows, eDC, SDTM);
• Demonstrated ability providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components).
• Demonstrated ability to work in a team environment with clinical team members.

Pay & Benefits:

The annual base salary for this position ranges from $175,000 to $190,000 depending on relevant skills, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance. Relocation assistance may be available based on business needs and/or eligibility.

EEO & Employment Eligibility:

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.

Privacy Policy:

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