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Sr / Pr Biostatistician - Immunology & Inflammation

Sr / Pr Biostatistician - Immunology & Inflammation

Syneos HealthMadrid, Comunidad de Madrid, España
Hace más de 30 días
Descripción del trabajo

Sr / Pr Biostatistician – Immunology & Inflammation

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

Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovate as a team to help our customers achieve their goals, and accelerate the delivery of therapies to change lives.

Why Syneos Health

  • We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards.
  • We are committed to our Total Self culture, where you can authentically be yourself.
  • We continuously build the company we want to work for and our customers want to work with by bringing together diverse perspectives so everyone feels they belong.

Job Responsibilities

  • Study lead 1‑2 protocol (late phase, phase 2‑3). Study responsibilities :
  • For phase 3, may support another main statistician.

  • IRT.
  • eCRF.
  • DMC set up.
  • Study risk management plan (SRMP).
  • Prepare SAP, tfls, STS.
  • Review specs.
  • Statistical surveillance (STS) : reviewing blinded data with 2‑3 STS meetings during study life.
  • Recruiting the right pts?
  • Data look okay?
  • Assess statistical assumptions?
  • Handling intercurrent events.
  • SAS or R.
  • May partially program efficacy.
  • Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
  • Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures; collaborates with the sponsor, if required.
  • May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
  • Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work; provides independent review of project work produced by other biostatisticians.
  • Creates / re‑views programming specifications for analysis datasets, tables, listings, and figures.
  • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.
  • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
  • Implements company objectives, and creates alternative solutions to address business and operational challenges.
  • Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives; prepares in advance for internal meetings, contributes ideas, and demonstrates respect for others’ opinions.
  • Manages scheduling and time constraints across multiple projects, sets goals based on priorities, adapts to timeline or priority changes, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
  • Monitors progress on study activities against agreed‑upon milestones and ensures the study timelines for project deliverables are met; identifies out‑of‑scope tasks and escalates to management.
  • Provides statistical programming support as needed.
  • May participate in Data Safety Monitoring Board and / or Data Monitoring Committee activities, including charter development and serving as an independent non‑voting biostatistician.
  • May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
  • Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
  • Maintains well‑organized, complete, and up‑to‑date project documentation, and verification / quality control documents and programs; ensures inspection readiness.
  • Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
  • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
  • Coaches and mentors other Biostatistics staff.
  • Performs other work‑related duties as assigned.
  • Minimal travel may be required.
  • Get to know Syneos Health

    Over the past 5 years, we have 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 take initiative and challenge the status quo with us in a highly competitive and ever‑changing environment.

    Seniority Level

  • Mid‑Senior level
  • Employment Type

  • Full‑time
  • Job Function

  • Research, Analyst, and Information Technology
  • Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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