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    Principal Biostatistician- Real World Evidence (Rwe)

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 Dec. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Principal Biostatistician - Real World Evidence (RWE)
    Updated: December 11, 2024
    Location: India-Asia Pacific - IND-Gurugram-DLF Downtown, India
    Job ID: 24006505-IND501

    Job Description

    Principal Biostatistician - Real World Evidence (RWE)

    Syneos Health® is a fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address the modern market realities.

    Our Clinical Development model places the customer and the patient at the center of everything we do. We continuously seek innovative ways to simplify and streamline our work, making Syneos Health easier to collaborate with and an even more rewarding place to work.

    Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll work alongside passionate problem solvers who collaborate as a team to help our customers achieve their goals. We are agile, driven, and passionate about accelerating the delivery of therapies that change lives.

    Discover what our 29,000 employees, across 110 countries, already know:
    WORK HERE MATTERS EVERYWHERE

    Why Syneos Health

    We are committed to developing our people through career growth, progression, technical training, and a total rewards program. Our Total Self culture fosters an environment where you can bring your authentic self to work. This culture of inclusivity helps us create a workplace where everyone belongs.

    Job Responsibilities

    • Serve as a resource in the statistical department, mentoring biostatisticians on job skills and overseeing training plans and materials for Biostatistics associates.
    • Direct activities of other biostatisticians, ensuring timely, high-quality work. Independently review project work produced by others in the department.
    • Provide statistical support throughout the project lifecycle, from protocol to Clinical Study Report (CSR).
    • Prepare or oversee the preparation of Statistical Analysis Plans (SAPs), including mock-up displays for tables, listings, and figures, in collaboration with the sponsor if required.
    • Lead or assist in developing the statistical aspects of protocols, including randomization schedules and clinical study reports.
    • Create or review programming specifications for analysis datasets, tables, listings, and figures.
    • Review SAS annotated case report forms (CRFs), database designs, and other study documentation to ensure data meets protocol requirements and supports high-quality database creation and analysis.
    • Collaborate with other departmental teams as the biostatistics representative on project teams.
    • Contribute ideas and demonstrate respect for others during internal meetings.
    • Participate in verification and quality control of project deliverables to ensure they meet expected results and align with the SAP.
    • May lead complex or multiple projects, attend regulatory meetings, and support statistical analysis results for clinical trials during submissions.
    • Manage scheduling and time constraints for multiple projects, proactively communicating timeline adjustments and challenges.
    • Monitor progress against milestones to ensure the study timelines are met. Identify and escalate out-of-scope tasks.
    • Provide statistical programming support as needed.
    • Participate in Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) activities as a non-voting or voting biostatistician.
    • Follow applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), and regulatory guidelines (e.g., ICH).
    • Ensure all project documentation is organized and inspection-ready.
    • Assist with business development activities, including proposal writing, budgeting, and attending sponsor bid defense meetings.
    • Perform additional duties as assigned. Minimal travel may be required.

    Qualifications

    What We’re Looking For:

    • PhD or MS in statistics or biostatistics with at least 2 years of experience in clinical trials or Real World Evidence (RWE) in the pharmaceutical or healthcare industry.
    • Expertise in RWE biostatistics, collaborating with cross-functional teams to design, analyze, and interpret RWE study results, and contribute to protocol development, statistical analysis plans, and regulatory submissions.
    • Proficiency in statistical programming (SAS, R, or Python) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation.
    • Extensive experience in clinical trials and the ability to lead multiple projects throughout the study lifecycle.
    • Knowledge of regulatory submissions is preferred.
    • Strong written and verbal communication skills.
    • Fluency in English (reading, writing, speaking, and comprehension).

    Get to Know Syneos Health

    Over the past five years, Syneos Health has worked with 94% of all Novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter what your role is, you'll challenge the status quo with us in a competitive, ever-changing environment. Learn more about Syneos Health and our impact on the biopharmaceutical industry.

    Additional Information

    The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign additional tasks or responsibilities as necessary. Equivalent experience, skills, and/or education will be considered. All job descriptions comply with applicable legislation and ensure equal opportunities in recruitment and employment practices.

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