Associate Director/Director, Statistical Programming

The Associate Director/Director of Statistical Programming will be responsible for the production of both formal and exploratory statistical outputs for a variety of purposes and stakeholders. This position will report into the Head of Biometrics and will interact regularly with internal and external biostatisticians, bioinformaticians, data scientists and programmers. Demonstrated ability to prioritize work and to effectively communicate and collaborate with key stakeholders both within Biometrics and beyond (research, translational science, clinical science, clinical operations and regulatory) is a must.

This is a unique opportunity to join a small but growing Biometrics team investigating a diverse portfolio of immuno-oncology therapeutics in early development. The ideal candidate will come with years of solid industry experience working in a regulated global environment while also demonstrating know-how, flexibility and scientific curiosity useful for establishing internal infrastructure, developing analysis standards, and driving both formal and exploratory work.

Job Duties and Responsibilities

• Produces and/or provides oversight for the production of statistical outputs and reports for clinical study teams and subfunctions

• Drives the development of standards, tools, and processes that improve the efficiency and rigor of analysis across clinical project teams

• Adopts strategic approach to producing and prioritizing analytical deliverables, incorporating innovative tools and methods where needed (pipelines, visualizations, dashboards via tools like Spotfire, Tableau, R-Shiny or similar)

• Effectively manages and oversees both internal and external programmers

• Builds solid collaborations with cross-functional study and project team members as well as internal and external data-facing stakeholders

• Performs stakeholder management, negotiating timelines and scope of deliverables (helping to balance team and company needs with speed, rigor and clarity of message)

• Provides leadership or project management to major data-heavy study or project team deliverables or initiatives

• Solid, demonstrated experience with CDASH and CDISC data standards (SDTM, ADaM) as well as health authority reporting requirements
• In-depth knowledge of data standards and demonstrated experience in the handling non-CRF data including proven ability to work with diverse data types

• Experience with validation at all levels, i.e., system requirements, data storage and curation requirements, software requirements as well as code validation and QC processes

Qualifications

Education/Experience

• Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience

• Minimum 6+ (Associate Director) or 9+ (Director) years of biotechnology or pharmaceutical experience, with (immuno-) oncology experience preferred

• Programming experience in SAS is a must. Experience working with other languages or software (R, Python, Spotfire) in validated environments strongly preferred

• In-depth knowledge in the analysis of clinical trial data, including integrated analysis of clinical trial data with other data types (biomarker, PK/PD, real-world, etc.)

Professional/Personal Requirements

• Demonstrated ability to rapidly adapt to changing project and strategic requirements
• Interest in continuing education, particularly in the areas of business knowledge as well as technology trends for producing analyses and visualizations (particularly with an eye towards reproducibility or interactivity)
• Takes a fit-for-purpose mindset to daily work as well as long-term vision