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Associate Director/Director of Statistical Programming
Job Description

Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.

Desired Candidate Profile

The Associate Director/Director of Statistical Programming will be responsible for daily statistical programming tasks for all phases of Annexon clinical trials including oversight of CRO statistical programming activities and support other functional areas such as data management and biostatistics. They will provide technical support for ongoing trials, FDA submissions, and development of initiatives at Annexon and expert-level, hands-on support and technical leadership to all clinical development programs and regulatory submissions. This position will report to the head of Biostatistics and will work closely with cross-functional teams on multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.

Specific Responsibilities:

  • Lead statistical programming oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, and approval of deliverables.
  • Participate and provide strategic guidance in study setup and initiation procedures such as case report form (CRF) design and review. Demonstrate extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry.
  • Efficiently manage CROs to meet timelines and quality deliveries. Oversee tables, figures, and listings (TFLs) production and validation, ensuring that CROs, vendors, and internal staff meet the highest quality standards per SOPs. Establish optimal relationships with internal customers and colleagues and with new or existing strategic partners and vendors.
  • Contribute to the strategic decision-making process involving data programming issues for ongoing early and late phase clinical trials. Communicate how programming decisions impact other functional areas at Annexon.
  • Write or review the data specifications for SDTM and ADaM. Create or validate SDTM, ADaM, and TLFs, including documentation (e.g., define.xml). Track and maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.
  • Provide input to key study documents such as CRFs, data management plans, database specifications, statistical analysis plans (SAPs), and other clinical documents.
  • Proficient in applying SAS programming knowledge to solve problems related to non-routine situations and experienced in interpreting SAPs and developing analysis data set specifications.
  • Work collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas; understand and perform in accordance with regulatory standards and drug development principles.
  • Responsible for the creation and accuracy of regulatory submission data and clinical summary report package; plan, develop, test, and document SAS programs and macros for programming efficiency.
  • Develop and utilize study metrics to monitor quality, project status, activities, and budget with Senior Director, Biostatistics to identify trends, implement corrective actions, and provide updates for improvements on study level operational performance and quality metrics.

Key Qualifications:

  • Bachelor’s Degree in Statistics, Mathematics, or Computer Science. Master’s Degree preferred.
  • Minimum 10 years of statistical programming experience in CRO, biotech, or pharmaceutical industry.
  • Strategic leadership in a cross-functional team setting with extensive experience in an outsourced model, EDC databases, CDASH, CDISC, and SDTM/ADaM standards, medical terminology, medical coding dictionaries, and quality control processes.
  • Strong hands-on SAS programing skills and working experience in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.
  • Advanced knowledge in GCP, ICH, GCP/ICH standards, 21 CFR Part 11, and FDA requirements, with prior experience filing NDA/MAA/BLA preferred.
  • Excellent working knowledge of SAS/BASE, SAS/STAT, SAS/GRAPH and SAS Macro languages.
  • Strong leadership, interpersonal, organizational, and multi-tasking skills, and ability to work within cross-functional teams.
  • Ability to manage multiple initiatives and shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
  • Annexon’s Associate Director/Director of Statistical Programming will be required to be fully vaccinated against the Covid-19 virus.  An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine.  You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.

Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.