Annexon Biosciences

Associate Director, Statistical Programming

Annexon Biosciences • $194K — $216K *
San Francisco, CA 94112In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • MS with 8+ years or BS with 10+ years in Statistical Programming leadership within pharma/biotech.
  • In-depth knowledge of CDISC standards for regulatory submissions.
  • Prior experience with FDA and EMA submissions.
  • Technical skills in statistical software like SAS and experimental design.
  • Understanding of GCP, ICH, 21 CFR Part 11 standards.
  • Ability to thrive in dynamic, collaborative environments.

Responsibilities

  • Manage timelines and oversight of outsourced statistical programming deliverables.
  • Serve as lead statistical programmer for clinical studies.
  • Conduct gap analysis and risk assessments for global submissions.
  • Review statistical analysis plans (SAP), TFL shells, and eCRFs.
  • Maintain thorough documentation for programming activities.
  • Verify CDISC SDTM/ADaM specifications and submission packages.
  • Support various requests for submissions and publications.

Benefits

  • Flexible work schedules and remote opportunities for work-life balance.
  • Shuttle service from BART, CalTrain, and the Ferry.
  • Competitive base salary with equity participation and stock purchase plan.
  • Comprehensive health benefits including medical, dental, and vision.
Full Job Description
Position:

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.

Responsibilities include:
  • 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.

Education, Experience, and Skills:

Required:
  • 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.

Preferred:
  • 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.

Salary Range: $194,000 - $216,000 USD

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.

Benefits:
  • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
  • Shuttle service from BART, CalTrain and the Ferry.
  • Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

About Annexon Biosciences

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. 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. Annexon is advancing a portfolio of product candidates into clinical development, including its lead program, ANX005, for the treatment of Guillain-Barré Syndrome and Warm Autoimmune Hemolytic Anemia. 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 exposure level, enabling the company to continue development with a high level of confidence in its approach.
Learn more about Annexon Biosciences
Size
30 employees
Market Cap
$917
Industry
Pharmaceuticals & Biotech
Founded
2011
NASDAQ
ANNX
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Annexon Biosciences

More Pharmaceuticals & Biotech Jobs

Find similar Associate Director, Statistical Programming jobs:

NationwideSan Francisco, CA