Associate Director, Statistical Programming
Company:
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.
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. 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!
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.
Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.
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.
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. 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!
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.
Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.