Associate Director, Statistical Programming

2 weeks ago

Durham, United States HUMACYTE GLOBAL INC Full time
Job DescriptionJob DescriptionJOB TITLE: Associate Director, Statistical Programming

DEPARTMENT: Clinical Operations

LOCATION: East Coast preferred, Partially Remote (periodic travel to HQ in Durham, NC required)

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm HAV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The Associate Director, Statistical Programming will lead the clinical Statistical Programming function with full accountability for SP activities including SDTM, ADaM and statistical outputs; will collaborate with partner functions in Clinical Development Department (e.g., Clinical Operation, Clinical Research, Biometrics) and oversee the vendor SP counterparts. The ideal candidate has demonstrated expertise and leadership on SP activities to support clinical development, regulatory submissions, and inspections.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Responsible for all SP deliverables in multi-disciplinary interactions.
  • Oversee the creation of SDTM, ADaM, statistical outputs and other SP deliverables.
  • Serve as in house SP point of contact in all interactions with vendors and key stakeholders.
  • Lead cross-functional collaborations on external data transfer and data integration.
  • Lead and oversee ongoing data review, cleaning, lock, transfer, and close-out activities.
  • Develop standards and establish best practices for SP function.
  • Perform ad hoc analysis to support clinical team needs and validate reports generated by other programmers
  • Evaluate resource needs and build the SP function at Humacyte.

EXPERIENCE & QUALIFICATIONS:

  • Bachelors required; masters preferred.
  • 8-10 years of relevant biopharma/CRO experience required; both sponsor and CRO experience highly desirable
  • Recent submission and inspection experience preferred; biotech experience, highly preferred.
  • Broad and advanced knowledge of SP and relevant disciplines related to clinical development and clinical studies.
  • Project management abilities including delegation, flexible team management, organization, analytical evaluation, negotiation, and resource management.
  • Excellent knowledge of managing operational challenges including managing conflict, statistical programming in SAS including Base, macro, STAT, GRAPH, SQL
  • Solid understanding of FDA, EMA, ICH and global regulations as well as CDISC and industry standards.

COMPENSATION & BENEFITS HIGHLIGHTS:

  • Competitive Base Salary, Annual Incentive Bonuses, and Stock Options
  • 401k Plan with 4% Match and no Vesting Schedule
  • Medical, Vision and Dental Plans
  • Company Paid Long Term/Short Term Disability
  • Company Paid Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 10 Company Designated Holidays + 2 Floating Holidays
  • Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters. **

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.

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