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Senior Manager/Associate Director, Statistical Programming

1 month ago
Anywhere
Full-time
Lead
QA Engineer
Data Science and Analytics
SAP
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 14

Description

  • Represent the statistical programming function in multidisciplinary team meetings.
  • Gather and clarify specification details needed for programming deliverables.
  • Review and approve SAPs and TFL shells before programming begins.
  • Provide input on study documents and external data specifications such as eCRFs, DMPs, DTAs, and inbound/outbound data specs.
  • Create or review CDISC-compliant datasets and documentation for regulatory submission.
  • Perform quality control on ADaM, SDTM, and SEND datasets, as well as tables, listings, figures, and derived outputs.
  • Ensure tables, figures, and listings are completed on time for electronic submission to regulatory agencies.
  • Develop SAS validation procedures and test plans as needed.
  • Support ad hoc, rapid-turnaround analyses for monitoring, safety, interim reporting, regulatory questions, and exploratory work.
  • Collaborate with statisticians, data managers, analysts, clinical staff, and CRO partners to ensure high-quality data and timely reporting.

Requirements

  • 8 to 12 years of industry experience in pharmaceuticals, biotechnology, or CRO environments.
  • Experience developing or overseeing submission-ready programming code for clinical trials using a SAS-based statistical computing environment.
  • Strong CRO oversight experience.
  • Hands-on SAS programming experience is required.
  • Knowledge of additional programming languages is a plus.
  • Experience in oncology clinical trials, especially solid tumors.
  • Good knowledge of statistics and the oncology drug development process.
  • Strong experience performing quality control of ADaM, SDTM, and SEND datasets and related metadata/specifications.
  • Solid verbal and written communication skills.
  • Ability to respond rapidly to ad hoc and emergent requests, reprioritize work, and manage interruptions while maintaining quality and timelines.

Benefits

  • Base salary range of $184,000 to $200,000.
  • Annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • Paid time off.
  • Paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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