Sr Biostatisticiansr Biostatistician

2+ years

Not Disclosed

India

10 March 9, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Senior Biostatistician

Updated: March 5, 2025
Location: India-Asia Pacific - IND-Home-Based, India
Job ID: 25001948

Description:
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 continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and for.

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 accelerate the delivery of therapies because we are passionate about changing lives.

Why Syneos Health:

We are passionate about developing our people through career development, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.
We are committed to our Total Self culture, where you can authentically be yourself.
We believe that diversity of thought, background, culture, and perspective creates a place where everyone belongs.

Job Responsibilities:

Provides support across all assigned statistical tasks during the project lifecycle, from protocol to CSR.
Prepares Statistical Analysis Plans (SAPs), including developing mock-up displays for tables, listings, and figures. Collaborates with the sponsor if required.
Responsible for the statistical aspects of the protocol, generation of randomization schedules, publications, and input to clinical study reports.
Coordinates biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high-quality work.
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 compliance with protocol criteria.
Conducts and participates in verification and quality control of project deliverables.
Implements company objectives and creates alternative solutions to address business and operational challenges.
Serves as a biostatistics representative on project teams, contributing ideas and respecting others' opinions.
Manages scheduling and time constraints across multiple projects, proactively communicating any challenges.
Monitors progress on study activities, ensures project deliverables meet timelines, and escalates out-of-scope tasks.
Provides statistical programming support as needed.
Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development.
May lead projects involving integrated analyses, attend regulatory agency meetings, or respond to questions supporting statistical analysis results.
Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
Maintains well-organized project documentation and verification/quality control documents.
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.

Qualifications:

Graduate degree in biostatistics or related discipline.
Moderate experience in clinical trials or an equivalent combination of education and experience.
Proficiency in programming.
Ability to apply statistical design, analysis, regulatory guidelines, and programming techniques in clinical research.
Experience in all statistical tasks supporting clinical trials during the project lifecycle.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.

Get to Know Syneos Health:
Over the past five 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.

Additional Information:
Tasks, duties, and responsibilities 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 responsibilities. Equivalent experience, skills, and/or education will also be considered. The company will determine what constitutes equivalency to the listed qualifications.

The company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when appropriate to assist employees or applicants in performing essential job functions.

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