Associate Director/Director of Statistical Programming

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At the company, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

What You'll Do

The Director of Statistical Programming will lead statistical programming activities for multiple studies and programming submission-related activities. In addition to working as a hands-on programmer for various internal requests, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions .

Responsibilities

(5-7 bullets max)

• Lead and manage statistical programming activities for multiple clinical studies, ensure statistical programming deliverables are delivered within timelines and with high quality and cross-study consistency

• Review CRO deliverables and perform acceptance check and validation to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards

• Manage, review, and/or execute statistical programming deliverables related to study monitoring, clinical study reports, data integrations, and regulatory query responses

• Collaborate with external alliances for all programming-related tasks to ensure successful and effective coordination and communications

• Set up SAS reporting environment, programming infrastructure, and utility macros library; Help bring state-of-the-art programming methods and tools to the organization and drive automation of delivery, including AI-assisted tools to improve programming efficiency, quality, regulatory and GDPR compliance

• Represent the statistical programming function in cross-functional study teams and collaborate with study teams to establish project timelines

• Identify, develop and maintain statistical programming standards, processes, and SOPs.

Where You'll Work

This is a U.S.-based remote role that will require bi-annually, or as needed visits to our San Francisco Office.

Who You Are

Historically the "Experience, Education, & Skills Requirement" section

(5-7 bullets max)

• MS in Statistics, Computer Science, or a related field with 10+ years of relevant experience, or BS in Statistics, Computer Science, or a related field with 12+ years of relevant experience. Minimum of 5 years of experience as a lead statistical programmer

• Extensive knowledge of CDISC standards and FDA SDTCG

• Experience of CRO oversight preferred

• Experience in NDA/BLA submission and advance knowledge of Regulatory & Compliance Requirements for Biostatistics processes

• Experience with statistical programming methods and processes in clinical development

• Ability to manage multiple projects in a fast-paced environment

• Experience integrating AI tools into clinical data pipelines and statistical workflows is highly desirable

At the company, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. The company is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary

$241,600 — $269,200 USD

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For the company Full-Time U.S Based Roles

Financial & Rewards

• Market-leading compensation

• 401(k) with employer match

• Employee Stock Purchase Program (ESPP)

• Pre-tax commuter benefits  (transit and parking)

• Referral bonus  for hired candidates

• Subsidized lunch and parking  on in-office days

Health & Well-Being

• 100% employer-paid medical, dental, and vision premiums  for you  and  your dependents

• Health Savings Account (HSA)  with annual employer contributions, plus  Flexible Spending Accounts (FSA)

• Fertility & family-forming benefits

• Expanded mental health support  (therapy and coaching resources)

• Hybrid work model  with flexibility

• Flexible, “take-what-you-need” paid time off  and company-paid holidays

• Comprehensive paid medical and parental leave  to care for yourself and your family

Skill Development & Career Paths

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

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