The Opportunity:

Position requires about 10-14 years of Statistical Programming experience with exploratory-stage oncology clinical trials, providing programming support and oversight of one or more clinical programs (early or late phase) within Statistical Programming function. In addition to direct programming and technical oversight of one or more studies, this position may require assistance providing technical support and guidance during regulatory submissions while ensuring conformance to CDISC standards and submission guidelines. Titles may vary based on candidate experience. Based on company needs, this position may be required to lead an early Phase or late phase study or program. Specific responsibilities include:

• Provide technical oversight of statistical programming resources including contractors and CROs.

• Provide mentorship to future leaders to help learn and execute on RevMed core values.

• Ensure quality and timely delivery of analysis for statistical programming deliverables.

• Provide solutions by analyzing issues and problems in complex situations.

• Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, academic community, and healthcare providers) via QC of documents with clinical data.

• Ensure that the statistical programming process conforms to the SOPs and regulatory standards where applicable.

• Timeline and vendor management for deliverables, including submission-related activities, complying with regulatory standards (e.g., FDA 21 CFR Part 11, GxP).

• Programming support for deliverables, such as Dose Committee meetings, Investigator Brochures, publications/presentations, US, and ex-US regulatory submissions.

• Proficiency in regulatory standards and compliance regulations including CDISC compliance (SDTM, ADaM, define.xml, Reviewer’s Guides, etc.).

Required Skills, Experience and Education:

• 10-14 years of Statistical Programming experience in biotechnology or pharmaceutical industry.

• BS/BA degree or other suitable qualification with relevance to the field.

• Direct statistical programming experience for early or late-phase clinical trials to support production/verification of analysis datasets, tables, listings, and figures.

• Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.

Preferred Skills:

• Early or late-stage oncology clinical trials.

• A demonstrable record of strong leadership and teamwork.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.

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