Principal Statistical Analyst

The Opportunity:

Position requires 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 hands-on Programming, this position requires providing oversight and programming support and guidance for internal deliverables and regulatory submissions while ensuring conformance to CDISC standards and submission guidelines. Based on company needs, this position will be required to lead one or more early Phase or late phase studies/programs. Specific responsibilities include:

• Effective collaborating with cross functional teams to provide programming timelines for various deliverables.

• Provide SAS Programming technical support and guidance to programming team.

• Oversight/participation in any internal/mock or regulatory authority audits.

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

• Oversee the programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer’s Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), blank and annotated CRFs, and actual patient CRFs.

• Hands-on programming and management of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.

• Oversight and Verification Review of documents, spreadsheets, slides for in-house presentations and external publications.

Titles may vary based on candidate experience.

Required Skills, Experience and Education:

•  14+ years of Statistical Programming experience with early or late phase oncology trial studies.

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

• Experience leading one or more statistical programming contractors, and programming vendors.

• Proficiency in providing hands-on SAS Programming support for production or validation 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:

• 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.

• Experience working in a small to mid sized biotech/pharma environment.

• Experience collaborating on development of processes, SOPs and guidance documents for the Statistical Programming function.

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