Associate Biostatistics Director
Alector, United States

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Jan 6, 2022
Last Date
Feb 6, 2022
Location(s)

Job Description

At Alector, our mission is to develop therapies that empower the immune system to cure neurodegeneration. Our team is solely focused on developing cures for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and board members, leading healthcare investors and some of the most innovative pharma companies.
Please join us in driving the development of new therapies that seek to transform patients' lives. If 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 Associate Biostatistics Director, you will provide statistical leadership, oversight, and expertise in support of the clinical development activities for multiple clinical studies. You will be responsible to provide statistic contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size/power calculations, Statistical Analysis Plan preparation/review, eCRF, entry guideline, and data transfer agreement review, data quality oversight, development of tables/listings/figures mockup, preparation documents for regulatory submission, and integrated safety and efficacy, DSUR, and IB reporting. You are expected to embrace the dynamic landscape, apply innovative statistical approaches to the trial design (e.g., modeling and simulation, adaptive design/Bayesian statistics); understand and present operating characteristics of different design, support and justify proper analyses and their unbiased interpretations in meetings and teleconferences with regulatory agencies and prepare written responses to agency questions. It is imperative that the associate director to partner with study teams and other functions which include statistical programming, data management, medical affairs, clinical science, clinical operations, medical writing, clinical pharmacology, pre-clinical, quality assurance, and regulatory personnel. The Associate Director will develop the ability to influence key decision makers within the project team and within senior management to ensure a high degree of rigor to the statistical and scientific decision-making process and outcomes.
Do you want to apply your existing technical skills, join a hard-working 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 goals will include:
  • Collaborate with internal and external collaborators in the optimized clinical study design, end point selection and sample size calculations, analysis, interpretation, and publication of clinical trial data
  • Implement protocols, statistical analysis plans, study reports, ensure statistical integrity of presentations and publications of clinical studies
  • Support project team and clinical study team including but not limited to 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 reviewing case report forms while managing workflow to ensure quality, prioritization, and timeliness across multiple programs
  • Provide statistical oversight in the development of key study documents including protocol, IB, SAP, Programming Mockup, CRF, CCG, and data transfer agreement.
  • Provide statistical analysis to different study endpoints and provide unbiased interpretation of study results.
  • 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 amp; 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 for 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
  • Good 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 activities from first-in-human testing to all later phases of clinical investigation, including pivotal Phase 2/3 st

Job Specification

Job Rewards and Benefits

Alector

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