Annexon Biosciences

Annexon Biosciences

Associate Director, Statistical Programming

San Francisco Bay Area · Director

Sponsorship not specified$194k-$216kDetected 5 days ago
GCPSAPClinical TrialsFDA RegulatorySASExperimental DesignLeadershipCollaboration

About the role

  • For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline.
  • We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.
  • We're seeking exceptional talent from all backgrounds to fuel our growth.

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.
  • 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.
  • Participate cross-functionally with key partners to advance Annexon products.
  • We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results.

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.

Skills

  • In-depth knowledge of CDISC standards.
  • Prior FDA and EMA submissions experience.
  • Understanding of GCP, ICH, 21 CFR Part 11 standards.
  • Work in dynamic, demanding and collaborative environment.
  • 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.
  • 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.

Compensation

  • $194,000 - $216,000

Benefits

  • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.

Company info

  • 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.
  • 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.
  • At Annexon, we're building a diverse, equitable, and inclusive workplace.
  • We value unique perspectives and unconventional paths.
  • If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply.
  • Learn more about our commitment to diversity, equity, inclusion, and our company culture!
  • 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.
  • 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.
  • include:

Equal opportunity

  • Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.

Visa & Work Authorization

  • Manage timelines and provide sponsor oversight for statistical programming deliverables outsourced to biometrics vendors (CROs) with full E2E traceability
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This listing is sourced directly from Annexon Biosciences's careers page and normalized into a canonical job model.