Biostatistician I, II or Senior – Clinical Trial Services

Location: Carlsbad, California US

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Job Id: 2637

Position Title: Biostatistician I, II, Senior

External Description:

Why should you considering joining us? Because Precision for Medicine, Oncology & Rare Disease is not your typical CRO. As a member of our thriving team, opportunities to work with leading subject matter experts who understand the rare disease patient mindset and experience will surround you. We help translate science into success for rare disease patients with a targeted, patient-centric approach over a wide geographic area. We are specialists who tackle unusual problems in our detailed approach throughout every phase. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first. We focus in an environment where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community.

We welcome your voice and opinions and provide you with the ability to truly make an impact on drug development. Are you ready to be part of a close-knit clinical trial team that is passionate about saving the lives of patients every single day? Then look no further, we’d like to help you take your career to the next level. If the duties below sound like a fit, we’d love to hear from you!

About You:

  • You are passionate about health care solutions in rare disease and oncology
  • You thrive in a fast paced environment while maintaining a high level of quality
  • You love working on a team and providing collaborative input to others, working well with data and project management
  • You are comfortable interpreting, communicating and presenting statistical results to non-statisticians providing explanations and answering the statistical or clinical questions to non-statisticians in simple terms
  • You are a strong SAS programmer, experienced in data manipulation and statistical analysis
  • You have excellent written and verbal communication skills
  • You are familiar with biostatistics-related industry standards and regulatory guidelines

What to expect day-to-day:

  • Generating randomization schedules and providing sample size calculations.
  • Providing input into development of case report forms (CRFs).
  • Authoring and reviewing statistical analysis plans, including development of table and listing shells.
  • Generating analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.
  • Providing programming support and quality control for SAS Programs and other study documents.
  • Providing statistical analysis and reports to Data Monitoring Committees (DMCs) and preparing clinical study reports.
  • Reviewing output across programs to ensure consistency.
  • Participating in the development and maintenance of SOPs.
  • Serving as the primary project team representative, delegating work as appropriate.
  • Training and mentoring new statisticians.

Qualifications:

Minimum Required:

  • MS or degree in Biotatistics/Statistics

Other Required:

  • Biostatistician I: entry level experience
  • Biostatistician II: 3 years experience
  • Senior: minimum 5 years experience
  • Senior Lead: minimum 7 years experience
  • Knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Experience with SAS.

Division: Precision For Medicine

Business Unit: Oncology & Rare Disease

Office Based: Carlsbad - 6005 Hidden Valley Road, Suite 170, Carlsbad, CA 92011

Employment Type: Exempt

Employment Status: Regular Full-time

Work From Home Available: No

City: Carlsbad

Country: United States

State: California

Community / Marketing Title: Biostatistician I, II or Senior – Clinical Trial Services

City: Carlsbad

State: California

Country: United States

Company Profile:

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

EEO Employer Verbiage:

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2018 Precision Medicine Group, LLC

Location_formattedLocationLong: Carlsbad, California US

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

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© 2019 Precision Medicine Group, LLC. All rights reserved