Director, Statistical Programming
The Director is the head of the Statistical Programming group within the Biostatistics function and will be responsible for all statistical programming activities pertaining to clinical development programs.
- Vendor selection and management, including writing RFPs, negotiating contracts and scopes of work, liaising between PaxVax Clinical and Data Management or Biostatistical vendors and consultants, review and monitor vendor budgets and timelines, adjusting if necessary, ensure vendor can meet both planned and unplanned PaxVax needs in a timely way.
- Responsible for the supervision and management of statistical programming staff and contractors, including hiring, motivation, training, coaching/mentoring, and performance evaluation; Provide staff with reliable guidance to succeed and grow.
- Ensuring the review of critical documents including protocols, Data Management Plans, Statistical Analysis Plans and mocks, Randomization Plans, CRFs, EDC build and edit check specifications, eCRF guidelines, DSMB I SMC charters, vendor deliverables, and data transfer agreements and specifications.
- Ensuring adequate and timely review of clinical data and its correctness and completeness for analysis milestones or data lock.
- Ensuring QC of deliverables such as EDC databases and randomization systems, QC programming of datasets and tables, listings, and graphs, and other submission deliverables including define documents, data guides, annotated CRFs, and computational methods descriptions.
- Develop departmental SOPs, guidelines, and technical documents. Assess and revise these documents as necessary.
- Liaise between Biostatistics Vendor, PaxVax Regulatory, and eCTD submission vendor for the preparation of module 5 materials, answering questions about the submission data standards, communicating with FDA experts, if necessary.
- Leadership with strong results orientation.
- Ability to work on and solve complex problems.
- Ability to prioritize and handle multiple tasks simultaneously.
- Ability to foster team productivity, cohesiveness, and collaboration.
- Has the ability to deal with competing timelines and multiple assignments.
- Strong communication (written and oral), negotiation, organizational, and interpersonal skills.
- Must be able to collaborate and work effectively with multiple departments throughout the organization.
- Must be able to work independently and as part of a team.
- 6 years' experience managing Statistical Programming functions, or equivalent
- Biostatistics vendor, budget, and timeline management experience
- Experience implementing clinical trials data review and analyses in SAS
- In depth knowledge of CDISC data standards and submission requirements
- Experience with developing infrastructure