Instagram
youtube
Facebook

Principal Biostatistician

3+ years
Preferred by Comapny
11 Nov. 25, 2024
Job Description
Job Type: Remote Education: PhD in Statistics or a related discipline with 3+ years of experience. MS in Statistics or a related discipline with 5+ years of experience. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Role OverviewStatistician

As a Statistician at Parexel, you will lead and coordinate project teams to ensure the successful completion of clinical studies, adhering to timelines and budgets while maintaining the highest quality standards. You will leverage advanced statistical methods and provide expertise in designing and analyzing clinical trials, contributing to data integrity and regulatory compliance. This role offers the opportunity to collaborate with clients, provide strategic input, and play a key role in shaping study outcomes.


Key Accountabilities

  1. Project Leadership and Coordination:

    • Lead project teams to achieve successful project outcomes within specified timelines and budget constraints.
    • Serve as the primary client contact for statistical and contractual discussions.
  2. Quality Control:

    • Perform quality control (QC) checks of derived datasets, tables, figures, and data listings produced by team members.
    • Ensure first-time quality through rigorous self-checking and adherence to standard procedures.
  3. Statistical Expertise:

    • Apply advanced statistical methods to clinical trial data.
    • Lead the production of randomizations, analysis plans, statistical reports, and other essential documentation.
    • Provide data and analysis as an independent, non-voting statistician for Data Monitoring Committee (DMC) reviews.
  4. Client Interaction and Support:

    • Actively engage with clients during study design discussions, analysis planning, and result presentations.
    • Contribute to Business Development by offering study design insights, discussing sample size scenarios, and participating in bid defense meetings.
  5. Documentation and Reporting:

    • Develop statistical sections for integrated clinical reports and process-supporting documents.
    • Maintain clear and comprehensive documentation to support regulatory and client requirements.
  6. Additional Responsibilities:

    • Contribute to and attend client meetings, offering analytical insights and presenting study outcomes.
    • Perform tasks as assigned by supervisors or managers to support the overall success of projects.

Skills and Competencies

  • Analytical Proficiency: Strong analytical and problem-solving skills.
  • Project Management: Effective project management capabilities to coordinate and drive project timelines.
  • Technical Expertise:
    • Proficiency in SAS programming.
    • In-depth understanding of statistical principles in clinical trials.
  • Leadership and Teamwork:
    • Strong leadership abilities to guide teams.
    • Willingness to work in a matrix environment and foster teamwork.
  • Communication: Professional attitude with strong written and verbal communication skills in English and local language.
  • Business Acumen: Awareness of business development processes and the ability to contribute strategically.
  • Attention to Detail: High attention to detail to ensure data quality and compliance.

Knowledge and Experience

  • Educational Background:

    • PhD in Statistics or a related discipline with 3+ years of experience.
    • MS in Statistics or a related discipline with 5+ years of experience.
  • Experience:

    • Proven expertise in statistical analysis for clinical trials.
    • Prior experience in SAS programming is required.

Join Parexel and be a part of a results-oriented team that values collaboration, innovation, and the highest standards of quality. This role offers an exciting opportunity to grow professionally while contributing to impactful clinical research.