Associate Biomarker Biostatistics Director

Biometrics and Digital Science        ·        South San Francisco, CA       ·       Full time 

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration. 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. Autonomy and collaboration in tackling challenges is what you are seeking and would like to be part of a hardworking team where everyone has a voice, please join in our mission!

As the Biostatistics Associate Director, focusing on biomarkers, you will be responsible for ensuring that biomarker data are generated appropriately to address relevant objectives such as the estimation of biological effects or the projection of clinical outcomes. This includes ensuring that studies are designed to answer specific and pertinent questions, that the analyses performed to account for various sources of variability and that the conclusions drawn are robust in the presence of multiplicity and confounding factors, especially as many biomarkers are multidimensional or may be an indirect measure of the clinical outcome.

You will ensure sound statistical thinking and methodologies are utilized in the design, analysis and statistical interpretation of studies focused on biomarkers and exploratory endpoints. Studies will include those support drug target discovery, target validation and confidence in rationale, and precision medicine in early-stage and late-stage clinical trials. You will have broad responsibility and contribute at early stages during pre-clinical development as well as across our therapeutic areas. Use your hard-earned biostatistics analytical and strategic skills to help us achieve our mission of saving lives by curing these diseases.

Do you want to apply your existing technical skills, join a high-performing team, learn and implement new capabilities? Do you get excited about solving problems in a fast-paced, and multi-tasked environment? Do you see digital and data as powerful tools to drive decisions, strategies, and create health care innovations? Work alongside curious, courageous, and collaborative people like you and help Alector achieve our missions. We want to hear from you!

During the first year, your goals will include:

• Integrate biomarkers across clinical trials and/or data registry in order to summarize and draw insightful inferences to help further advancing the drug development programs by using appropriate statistical techniques such as propensity score matching and meta-analysis
• Lead in development and adaptation of new statistical methodologies in support of Alector’s drug development
• Conduct analyses on biomarker data and develop summaries by implementing appropriate statistical methodologies and data visualizations
• Collaborate strategically with internal and external partners in the optimized clinical study design, end point selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
• Execute protocols, statistical analysis plans, study reports, ensure statistical integrity of presentations and publications of clinical studies by applying your past experience
• Participate in establishing and maintaining policies, standards and guidance for Biostatistical operations
• Lead Biometrics & Digital Science Department Initiatives
• Support clinical study team including but not limited to hands-on generation of data visualizations and summary reports 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
• Oversee outsourced development of analysis data and results, and manage biomarker workflow to ensure quality, prioritization, and timeliness across multiple programs
• Manage external vendors and serve as a key biomarker-Biostats liaison with external organizations
• 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 6-8 years, or MS with 8-10 years of proven experience in academia or industry. Pharmaceutical/biotech industry experience preferred
• Strong analytical and problem-solving skills with a keen understanding of statistical principles and concepts
• Expertise in biomarker analysis and data mining methodologies, including statistical modeling and simulation, and machine learning
• Experience working with multi-dimensional biomarker data, and multi-modal data integration
• Hands on ability to drive and lead statistical strategies pertinent to biomarkers 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
• Ability to work both independently and collaboratively across functional teams
• Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
• Advanced programming skills in R and/or SAS and other relevant statistical software solutions.
• Working knowledge of Github and Markdown preferred.

#LI-BL1

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Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a treatment, where you’ll drive growth, this is your role. There is no limit to how far you can go with us.

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 the heart of the biotech area, flexible remote work options, and competitive compensation and benefits. But these matters only if you’re excited to build and own something great, and tackle these challenges with us. 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, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Please click here to apply.