Director, Biostatistics

Director, Biostatistics

South San Francisco, CA /

Biometrics and Digital Science /

Full-time

/ On-site

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer . Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

Please join us in driving the development of new therapies that seek to transform patients' lives. If autonomy and collaboration in tackling challenges are what you are seeking and would like to be part of a hardworking team where everyone has a voice, please join our mission!

As the Biostatistics Director, you will provide statistical leadership and expertise supporting the clinical development activities for multiple therapeutic areas. You will be responsible to provide statistics and contribute strategically to project decisions. You are expected to apply innovative statistical approaches to the work (e.g, modeling and simulation, adaptive design/Bayesian statistics); support and defend analyses and their interpretations in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions.

The director will partner with project teams and other functions which include statistical programming, data management, medical affairs, clinical science, clinical operations, medical writing, and regulatory personnel. You will influence key decision-makers within the project team and senior management to ensure a high degree of rigor in the statistical and scientific decision-making process and outcomes.

Do you want to apply your existing technical skills, join an hardworking team and learn and implement new capabilities? Can you see yourself playing a key role in clinical development and trial design for our antibody therapeutics? If so, we want to hear from you.

During your first year, your responsibilities and goals will include:

• Define how you will contribute to Alector's overall 3-5 year vision to continually improve our clinical development strategy
• Collaborate with internal and external stakeholders in the optimized clinical study design, endpoint selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
• Execute protocols, statistical analysis plans, and study reports, ensure statistical integrity of presentations and publications of clinical studies
• Support the project and clinical study teams including but not limited to the derivation of go/no-go criteria, generation of data visualizations and summary reports, and interpretation of results to support internal decision-making
• Participate in regulatory interactions (IND/CTA filings, annual safety reporting) and responsible for biostatistics input into study protocols and clinical study reports
• Review study randomization specifications, oversee outsourced development of analysis data and results; and review case report forms while managing workflow to ensure quality, prioritization, and timeliness across multiple programs
• Manage external vendors and serve as a key Biostats liaison with external organizations
• Participate in establishing and maintaining policies, standards, and guidance for Biostatistical operations
• Lead Biometrics & Digital Science Department Initiatives
• Ensure up to date knowledge of industry and academic developments in the Neuroscience, Immuno-Oncology, and Orphan disease fields and apply to clinical study design and analysis

We'd love to hear from you if you have:

• PhD with 8-10 years, or MS with 10-12 years of proven experience in academia or industry. Pharmaceutical/biotech industry experience preferred
• Strong knowledge of theoretical and applied statistics
• Experience with multivariate statistics and statistical methods to quantify uncertainty in multi-dimensional data; experience running simulations and mixed models
• Hands-on ability to drive and lead statistical strategies for clinical development of drug candidates from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 studies and NDA/BLA submissions
• Demonstrated success in leading the statistical strategy, analysis and design of a clinical development program
• Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
• Advanced programming skills in SAS and/or R and other relevant statistical software solutions.
• Ability to code programs to analyze and report complex clinical trial data, as well as for electronic review, exchange, transformation, and submission of data in CDlSC, SDTM and ADaM formats
• Strong application of innovative study designs and developing landmark criteria (e.g. Go/No Go criteria).
• Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and data modeling is strongly preferred

#LI-BL1

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Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune's " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022 .

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other's assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.