Director, Biostatistics

Company Summary

Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond. 

Work Location:   Hybrid - Remote assignment will be considered

Position Summary

Director of Biostatistics is responsible for providing statistical expertise and managing the activities for multiple clinical programs, to ensure valid and efficient study designs that allow clearly interpretable results, and timely delivery of analyses, reports, and regulatory documents with high quality. He/she builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework. The individual will serve as an internal expert in the assigned programs and will manage vendors for outsourced statistical and programming related activities to ensure highest quality of all deliverables within the budgets and timelines. The individual will participate in the long-term growth strategy of the department, including process improvement, standardization, SOP development, and statistical methodology development.

This position will report to 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.  

Responsibilities

• Serve as the lead statistician with responsibility for all biostatistics deliverables across assigned clinical development programs through own effort and/or management CROs.
• Collaborates with project team members to generate clinical protocol, review/author statistical analysis plan/table, listing, & figure shells, programming specifications, CRFs, and CRF edit checks, CDISC SDTM and ADaM data sets specifications and documentation, clinical study reports, regulatory submissions, annual DSUR and safety reports, and publications.
• Demonstrate extensive understanding of statistical concepts and methodology for clinical drug development. Propose novel statistical methodological approaches to design of scientific studies. Provide sufficient detail to allow programming implementation. Ensure that all statistical analyses specified in scientific protocols and statistical analysis plans are designed and conducted appropriately.
• Key player in the execution of the clinical development plan for the assigned project; provides strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis, and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, BLAs, NDAs and MAAs. 
• Participates in approved process improvement initiatives; keeps up to date current on statistical methodology and computing development. Conducts modelling and simulations as needed.                                                                                                                                                                                                  

Key Qualifications:

• PhD in Biostatistics/Statistics or equivalent with a minimum of 7-8 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 9-10 years relevant experience
• Substantial past regulatory interactions, including submissions. 
• Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
• Ability to develop innovative/creative statistical/technical solutions to complex problems.
• Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
• Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.
• Knowledge of statistical programming languages.
• Strong verbal and written communication skills.
• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership.

Annexon Biosciences requires that all employees 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.

DIVERSITY, EQUITY, INCLUSION, BELONGING ARE IMPORTANT TO US

We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve.

Internally, we want to make sure all employees feel welcome, appreciated and can be themselves at Annexon. We continually educate, inform and hold accountability for improving our diversity, equity, inclusion and belonging efforts. We ensure that open and real dialogue happens on important diversity topics.

Externally, we continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented businesses have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate.

The anticipated starting salary for the Director, Biostatistics position is $217,519 - $241,688 per year. The starting salary for this position will be determined based on the candidate’s education, experience, transferable skills, licenses/certifications, location, and will be reviewed on a case-by-case basis to determine the final compensation. The starting salary does not include any other potential components of the total compensation package, including bonus, equity, employer provided benefits, and perks.

Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.”

Annexon Biosciences doesn't accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences.