Sr Biostatistician (Therapeutic Areas -Oncology / Vaccines)

Description

Sr Biostatistician (Therapeutic Areas -Oncology / Vaccines)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
. We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program.
. We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• 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. Collaborate 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 in the department.
  . Creates or reviews 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 and all data is captured as required to support a high quality
  database and the planned analysis.
  . 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 create alternative solutions to address business and operational
  challenges.
  . Serves as biostatistics representative on project teams, interfacing as necessary with other
  departmental project team representatives. This would include preparing in advance for internal
  meetings, contributing ideas, and demonstrating respect for opinions of others.
  . Manages scheduling and time constraints across multiple projects, sets goals based on priorities from
  management, adapts to timeline or priority changes by reorganizing daily workload, 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

• Experience - Senior Biostatistician (5 Years to 8 Years).

• Primary Skills - Relevant experience as Statistician working on activities like SAP writing, Mock shell creations & Randomization(Good to have), CSR review, Estimand Framework, Bayesian(Good to have).

• Experience on any clinical trial phases with RWE-EHR (Electronic Health Records),claims, registries, R(Proficient) & Efficacy is Mandatory to have.

• CDISC, Sas experience with lead Statistician experience.

• Exp on any Therapeutic areas is okay :Oncology is good to have

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 the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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.

Summary

Senior Biostatistician- RWE This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects.