Associate Director, Biometrics

Ionis Pharmaceuticals, Inc.; Carlsbad (CA); On-site; USD 165,000 - 223,000; Full time

Benefits offered by this job

Relocation assistance

Full benefits package

Job summary

Ionis Pharmaceuticals, Inc. in Carlsbad, CA seeks Associate Director, Biometrics to lead biostatistics across clinical development, shape study design and ensure regulatory-standard analyses.

The role requires a PhD or master's with substantial experience, expertise in SAS/R and CDISC, and strong communication; onsite with relocation support available.

Qualifications

• PhD in Statistics or Biostatistics with 5+ years of relevant experience, or a Master's with 8+ years.
• Proficient in SAS and R programming.
• Deep knowledge of CDISC standards and their application.
• Excellent verbal and written communication.

Responsibilities

• Provide statistical leadership and independent guidance for assigned clinical development programs/projects, including study design, analysis, interpretation, and development strategy.
• Serve as the statistical lead on cross-functional study and project teams and provide recommendations on complex statistical issues.
• Lead statistical strategy and execution across assigned studies, ensuring scientific rigor, consistency, and alignment with regulatory and industry standards.
• Design clinical trials and provide sound statistical guidance on clinical development projects
• Provide sample size estimates for proposed studies
• Write statistical section of study protocols, statistical analysis plans and study reports
• Develop clinical trial randomization
• Review study protocols, CRFs, database structures, study reports and annual reports
• Lead study or project team in the review and discussion of SAP
• Oversee CRO statistical activities and deliverables, including quality, timelines, and implementation of statistical analysis plans.
• Maintain study documentation of statistical analyses and supportive documents.
• Other duties as assigned.

Skills

Statistical leadership

Cross-functional collaboration

Advanced communication skills

Problem solving

Education

PhD in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

SAS

R

CDISC standards

Job description

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

ASSOCIATE DIRECTOR, BIOMETRICS

Summary

The Associate Director, Biometrics is an experienced leadership position requiring broad knowledge and sound judgement within biostatistics. One will be responsible for the Biostatistics components of each assigned project, including study design, documents review for other functions, statistical analysis results, and oversee CRO. In each clinical development across indications, this role is contributing to therapeutic area strategy to ensure operational efficiency of Biostatistics elements and high scientific integrity.

WORK LOCATION

This position is based in our Carlsbad, CA campus and onsite work is preferred. Remote work may be considered. Relocation assistance is available for eligible candidates.

Responsibilities

• Provide statistical leadership and independent guidance for assigned clinical development programs/projects, including study design, analysis, interpretation, and development strategy.
  • Serve as the statistical lead on cross-functional study and project teams and provide recommendations on complex statistical issues.
  • Lead statistical strategy and execution across assigned studies, ensuring scientific rigor, consistency, and alignment with regulatory and industry standards.
• Design clinical trials and provide sound statistical guidance on clinical development projects
  • Provide sample size estimates for proposed studies
  • Write statistical section of study protocols, statistical analysis plans and study reports
  • Develop clinical trial randomization
  • Review study protocols, CRFs, database structures, study reports and annual reports
  • Lead study or project team in the review and discussion of SAP
• Oversee CRO statistical activities and deliverables, including quality, timelines, and implementation of statistical analysis plans.
• Maintain study documentation of statistical analyses and supportive documents.
• Other duties as assigned.

Requirements

• PhD degree in Statistics, Biostatistics or related field, and at least 5 years of relevant experience, or a master’s degree in Statistics, Biostatistics or related field, and at least 8 years of relevant experience
• Proficient with SAS programming and other statistical software (e.g., R)
• Proven knowledge of CDISC (Clinical Data Interchange Standards Consortium) standards and application of those standards to projects
• Demonstrates advanced oral and written communication skills

The pay scale for this position is $164,760 to $222,888.

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Ionis offers an excellent benefits package!

Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits