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Director/Sr. Director, Clinical Statistical Programming (Must Have Biotech/Pharma Experience)

Scorpion Therapeutics

Scorpion Therapeutics

San Francisco, CA, USA
Posted on Saturday, June 1, 2024

Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data sciences, with the goal of consistently and rapidly creating exquisitely selective small molecule compounds against an unprecedented spectrum of targets. Scorpion aims to leverage its platform to advance a broad pipeline of wholly owned, optimized compounds across three target categories: best-in-class molecules targeting validated oncogene targets; first-in-class molecules for previously undruggable targets; and first-in-class molecules for novel cancer targets.

Position Overview:

We are seeking a highly skilled and experienced Director/Sr. Director of Clinical Statistical Programming to join our dynamic Biometrics team. The ideal candidate will lead and manage the clinical statistical programming function, ensuring the highest standards of quality and efficiency in the analysis and reporting of clinical trial data. This role will be pivotal in advancing our clinical development programs and contributing to the overall success of our innovative oncology pipeline.

Key Responsibilities:

  • Lead and manage the clinical statistical programming team, providing strategic direction, mentorship, and professional development.
  • Oversee the development, validation, and implementation of statistical programs for the analysis and reporting of clinical trial data.
  • Collaborate closely with biostatisticians, data management, and clinical operations teams to ensure seamless data flow and integration.
  • Ensure compliance with regulatory requirements, industry standards, and company policies for statistical programming and data analysis.
  • Develop and maintain programming standards, templates, and best practices to enhance efficiency and consistency.
  • Contribute to the review and approval of statistical analysis plans (SAPs), data management plans (DMPs), and other relevant documentation.
  • Contribute to the preparation of regulatory submissions, clinical study reports (CSRs), and publications.
  • Stay current with advancements in statistical programming tools, technologies, and methodologies to drive continuous improvement.

Qualifications:

  • Advanced degree (MS/PhD) in Biostatistics, Statistics, Computer Science, or a related field.
  • Minimum of 10 years of experience in clinical statistical programming within the pharmaceutical or biotechnology industry.
  • Proven track record of leading and managing high-performing statistical programming teams.
  • Expertise in SAS programming and other relevant statistical software.
  • In-depth knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements (e.g., FDA, EMA).
  • Strong understanding of clinical trial design, data management, and biostatistics.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively across functional areas.
  • Ability to work in a fast-paced, dynamic environment and manage multiple priorities.

Scorpion Therapeutics Inc. is an Equal Opportunity Employer who strives to create and maintain a diverse working environment. We do not discriminate for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Beginning October 13, 2021, Scorpion Therapeutics requires all new hires to be fully vaccinated against COVID-19. If you are unable to receive the vaccine due to a disability or serious medical condition, or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.