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Uniquity Bio

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Uniquity Bio

Senior Director, Biostatistics

Malvern, PA · Remote

Uniquity Bio is seeking an experienced and strategic Senior Director, Biostatistics to provide statistical leadership across one or more clinical development programs within a fast-paced and highly ...

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Senior Director, Head of Statistical Programming

Uniquity Bio

Malvern, PA • Remote

Full-time

Posted 2 days ago

Job description

Uniquity Bio is seeking a highly experienced and strategic Senior Director, Head of Statistical Programming to lead and scale the Statistical Programming function within our growing Biostatistics and Data Sciences organization. This individual will provide both strategic and operational leadership across clinical development programs and will be responsible for the delivery, quality, and integrity of statistical programming outputs supporting clinical trials, regulatory submissions, publications, and internal decision-making.


The Senior Director will play a critical role in establishing programming standards, building scalable infrastructure, and driving operational excellence across all programming activities. This position requires deep technical expertise, strong leadership capabilities, and the ability to collaborate effectively within a dynamic, cross-functional biotechnology environment.


The ideal candidate is a hands-on leader with extensive experience supporting regulatory submissions, managing external vendors and CROs, and building high-performing programming organizations within a fast-paced clinical-stage biotech setting.

Key Responsibilities:

  • Define and lead the vision, standards, operational strategy, and long-term scalability roadmap for the Statistical Programming function.
  • Build, mentor, and develop internal statistical programming capabilities through strategic hiring, coaching, resource planning, and team leadership.
  • Oversee the development, validation, review, and delivery of SDTM datasets, ADaM datasets, tables, listings, figures (TLFs), and related programming deliverables across clinical development programs.
  • Ensure all programming deliverables meet internal quality standards, CDISC compliance requirements, and applicable regulatory expectations for global submissions.
  • Provide technical and operational oversight for programming activities supporting clinical trials, regulatory submissions, publications, safety analyses, and ad hoc data requests.
  • Drive programming strategy and readiness for regulatory interactions and submissions, including FDA, EMA, PMDA, NDA, BLA, and MAA activities.
  • Establish, maintain, and optimize programming processes, standards, SOPs, macros, validation frameworks, and data governance workflows to improve consistency, efficiency, scalability, and inspection readiness.
  • Lead and oversee relationships with external CROs, statistical programming vendors, and independent contractors, including scope management, quality oversight, timeline accountability, and budget management.
  • Partner closely with Biostatistics, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, and Clinical Development teams to ensure alignment on study timelines, deliverables, and data quality expectations.
  • Contribute to submission strategy discussions, inspection readiness activities, and responses to regulatory questions related to programming deliverables and data standards.
  • Evaluate and implement innovative technologies, tools, and automation opportunities to enhance programming efficiency and reproducibility.
  • Support organizational growth initiatives and contribute to broader departmental strategy and operational planning efforts.


Qualifications:

  • Bachelor’s, Master’s, or PhD in Statistics, Biostatistics, Computer Science, Mathematics, or related quantitative discipline.
  • Typically, 12+ years of statistical programming experience within the biotechnology, pharmaceutical, or CRO industry, including leadership experience supporting clinical development programs.
  • Demonstrated experience leading statistical programming activities across multiple phases of clinical development, including late-stage studies and regulatory submissions.
  • Deep expertise in CDISC standards, including SDTM and ADaM implementation.
  • Expert-level proficiency in SAS required; familiarity with R and/or Python strongly preferred.
  • Strong understanding of clinical trial processes, regulatory requirements, and industry best practices related to statistical programming and submission deliverables.
  • Proven experience managing external CROs, vendors, and outsourced programming models within a matrixed environment.
  • Demonstrated ability to establish scalable programming standards, processes, and operational infrastructure within a growing organization.
  • Prior experience supporting FDA, EMA, PMDA, NDA, BLA, and/or MAA submissions strongly preferred.
  • Excellent leadership, communication, collaboration, and organizational skills with the ability to influence across cross-functional teams and executive stakeholders.
  • Ability to thrive in a fast-paced, highly collaborative, and evolving biotechnology environment.


Why Join Uniquity

Uniquity Bio is a fast-paced and rapidly growing organization where ideas matter and people make the difference. The company seeks to identify leaders who are mission-driven self-starters and are comfortable working within a complex and dynamic environment.


At Uniquity, we are building a culture of curiosity, accountability, and collaboration. We are seeking leaders who are energized by growth, motivated by impact and ready to build an organization where people and science thrive together.

This role offers the opportunity to directly influence clinical development strategy and operational execution during a critical stage of company growth while helping shape the future of the Clinical Operations organization.


Work Environment

This is a small, fast-paced organization. Candidates must be self-starters who are comfortable working both independently and in collaboration with a team comprised of in-house and external team members. The ability to be productive and successful in a dynamic work environment is critical.


The position is US based. Team members who live within commuting distance to either our Malvern, PA or San Diego, CA office locations are expected to spend the majority of their work time physically present in the office interacting with other team members. Remote employees will be expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed on a case-by-case basis with the employee’s manager.


Business travel may be required depending upon the specific needs of the position.

The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.