Associate Director, Statistical Programming

Annexon Biosciences•Brisbane, CA

4d•$194,000 - $216,000•Hybrid

About The Position

At Annexon Biosciences, we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together. Reporting to the Head of Statistical Programming, this individual independently operates and oversees the development and delivery of statistical programming solutions for all Annexon clinical trials and regulatory submissions. A highly visible and collaborative role, the Associate Director of Statistical Programming partners cross-functionally to advance medicines to our patients.

Requirements

MS with 8+ years of experience or BS with 10+ years of experience in the pharmaceutical or biotechnology industry in a Statistical Programming leadership capacity.
In-depth knowledge of CDISC standards.
Prior FDA and EMA submissions experience.
Technical expertise and knowledge of experimental design and analyses using statistical software such as SAS etc.
Understanding of GCP, ICH, 21 CFR Part 11 standards.
Work in dynamic, demanding and collaborative environment.

Nice To Haves

Ability to communicate with clarity and influence including explaining complex quantitative issues in simple terms.
Solid understanding of Regulatory (FDA/EMA/ICH) guidance with the ability to interpret and apply in real-time drug development setting.
Understanding of regulatory submission and approval process.
Ability to effectively collaborate and influence throughout multiple levels of the organization.
Strategic and creative drug-development mindset/approach.
Ability to balance appropriate levels of structure/process with efficiency and simplicity.
Awareness of external industry landscape with respect to best practices and emerging topics.

Responsibilities

Manage timelines and provide sponsor oversight for statistical programming deliverables outsourced to biometrics vendors (CROs) with full E2E traceability.
Serve as lead statistical programmer on one or more clinical studies.
Conducts gap analysis and risk assessments for global submissions such as BLA/MAA etc.
Reviews SAP, TFL shells, eCRFs etc.
Maintain complete and auditable documentation for all statistical programming activities.
Develop and/or verify CDISC SDTM/ADaM specifications, datasets and eCRT submission packages such as define.xml, reviewer’s guide’s etc.
Support supplemental/ad hoc/post hoc requests for submissions, publications and manuscripts.
Provide guidance to project/study teams.
Participate cross-functionally with key partners to advance Annexon products.
Contribute to and participate in the development and maintenance of a positive team-focused company culture.