Principal Statistical Programmer

The Principal Statistical Programmer will be responsible for the submission readiness of study data packages per CDISC standards and FDA guidance, planning, execution, and quality of statistical analyses, and statistical programming infrastructure. This position will report into the Head of Statistical Programming and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members. 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 an 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.

Responsibilities

  • Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review
  • 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)
  • Work with data management to review case report forms, database specifications, and data transfer specifications
  • Manage on-time and quality delivery of CRO-generated analyses results
  • 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
  • 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
  • Participate in standards governance and developing biometric department operational processes.
  • Work with the Head of Statistical Programming to establish and implement programming standards for validation, repeated use, and TMF archival of statistical programs and datasets

Qualifications

  • 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 5+ 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.)
  • Experience managing delivery of statistical programming projects by CROs
  • 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

This role can be remote based. The anticipated salary range for fully qualified candidates applying for this position is 25-30 LPA. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here:CJNovum.com.

EOE

CJ Novum is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets. Please send your resumes/CVs at the email address below Info@CJNovum.com

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