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TSP
Bothell, WA | Other
$190k-242k (estimate)
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Director, Biostatistics
TSP Bothell, WA
$190k-242k (estimate)
Other | Business Services 3 Months Ago
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TSP is Hiring a Director, Biostatistics Near Bothell, WA

Description

Classification:Exempt
Reports to:Chief Medical Officer
Purpose
The Director, Biostatistics provides statistical expertise in the validation of assays for phase II and III vaccine studies and reports clinical study data ensuring timelines and company strategic objectives are met.
Key Roles & Responsibilities
  • Perform trial statistician responsibilities including reviewing CRFs, reviewing protocols/amendments, developing the Statistical Analysis Plan, and conducting pot hoc and exploratory data analyses.
  • Write the statistical methods sections of integrated study reports.
  • Verify phase II/III data from ICF assay validation, removing bias.
  • Oversee vendor statistical projects with high quality and on-time completion.
  • Data monitoring committee (DMC) support including charter, tables, figures, and listings preparation.

Preferred Education

  • Master’s degree in Biostatistics, Statistics, or a closely related discipline.
Preferred Experience
  • At least 5 years of experience working as a biostatistician. Vaccine experience is preferred, but not required.
  • Proficiency in statistical software packages (e.g., SAS, R) and programming languages commonly used.
  • Experience using CDISC data standards, specifically ADaM.
  • Experience analyzing and verifying data for ICS (intracellular cytokine staining) assays.
  • Working knowledge of clinical research, Good Clinical Practices, and regulatory guidelines.
  • Experience supporting clinical studies, including developing Statistical Analysis Plans, study protocol drafting/reviewing, data review, and analysis.
  • Experience using statistical techniques including generalized linear models, mixed effect models, Cox modeling, time series, non-parametric and Bayesian techniques, machine learning, descriptive statistics, and graphical methods.
  • Lead and manage statistical programming responsible for developing, validating, and maintaining programs for data analysis and reporting.
  • Ability to successfully partner with vendors to achieve results.
  • Strong problem-solving and decision-making abilities, with a focus on delivering high-quality results within timelines.
  • Excellent organizational and project management skills, with the ability to prioritize tasks, meet deadlines, and manage budgets effectively.

Knowledge, Skills and Abilities

  • Excellent written communication skills.
  • Ability to work autonomously and multi-task in a fast-paced environment.
  • Ability to act with integrity, and professionalism, and maintain confidentiality.
  • Strong analytical and problem-solving skills.
  • Team player, with the ability to work successfully across functions.
Physical Demands
Performing the responsibilities of the job requires the ability to use hands and fingers to handle or feel and manipulate keys on a keyboard. Occasionally required to stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl. Ability to read and type while sitting in front of a computer for up to 4 hours at a time. Vision abilities required by this job include close vision. May occasionally have to lift, tug, and pull up to 25 lbs.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Curevo offers its employees a generous range of compensation and benefits.

The salary range for this position is $170,000 - $225,000 annually. The salary range may vary based on Curevo’s compensation practices and an applicant’s qualifications and experience.

Employees have the opportunity to earn an Annual Discretionary Bonus as well as being eligible to participate in Curevo’s Discretionary Equity Awards Plan. Our Employee Benefits program includes medical, dental, and vision plans, effective on the first of the month after your hire date, Flexible Spending Account, Health Savings Account, company provided Life and AD&D Insurance as well as LTD Insurance, a 401(k) Plan (eligible on day 1) with company match, cell phone reimbursement, and a variety of supplemental benefits that you may choose to elect. We have a Flexible Vacation Plan, a Paid Sick Leave Plan earning 1 hour of sick time for 30 hours worked, and 10 paid holidays per year.

At Curevo, we believe the highest-performing teams include people from a variety of backgrounds and experiences who respectfully challenge each other and enjoy working and engaging together. We are committed to building an open, diverse, and inclusive culture for all employees.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

Curevo is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status, or any other characteristics protected under applicable federal, state, and local laws.

About Curevo Vaccine

Curevo Vaccine is a clinical-stage biotech company pioneering the development of vaccines for unmet needs. Our overall goal is to bring a safer, well-tolerated, highly effective shingles vaccine to the market with a high-yield manufacturing process for rapid global availability.

Attention: Search Firms / 3rd Party Recruitment Agencies

The Talent Acquisition / HR team manages the recruiting for all positions at Curevo Vaccines. We will only accept resumes from a search agency/recruiter if we have a signed agreement in place and the Talent Acquisition / HR team has formally requested your help on a specific role. Unsolicited resumes sent to Curevo Vaccine will be considered property of Curevo Vaccine. Curevo Vaccine will not be responsible for any fees associated should we hire from unsolicited resumes.

Recruiters are requested not to contact or present candidates directly to our hiring managers or employees and doing so may jeopardize eligibility to work on future positions.

Job Summary

JOB TYPE

Other

INDUSTRY

Business Services

SALARY

$190k-242k (estimate)

POST DATE

03/06/2024

EXPIRATION DATE

07/01/2024

WEBSITE

taylor-strategy.com

HEADQUARTERS

COLUMBUS, OH

SIZE

50 - 100

TYPE

Private

CEO

MIKE GAMBLE

REVENUE

$10M - $50M

INDUSTRY

Business Services

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