Senior Principal Statistical Programmer (Adam, Tlf's, Sdtm)

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

Senior Principal Statistical Programmer (ADaM, TLF's, SDTM)
Updated: December 12, 2024
Location: India-Asia Pacific - IND-Home-Based, India
Job ID: 24006554

Job Description

Senior Principal Statistical Programmer (ADaM, TLF's, SDTM)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We translate clinical, medical affairs, and commercial insights into outcomes that meet the demands of modern markets.

Our Clinical Development model puts the customer and the patient at the center of everything we do. We’re committed to simplifying and streamlining our operations, making Syneos Health not only easier to work with but also a better place to work.

Whether you join us as part of a Functional Service Provider partnership or in a Full-Service environment, you'll collaborate with passionate problem solvers, working together to help our customers achieve their goals. We are driven to accelerate the delivery of therapies because we are passionate about changing lives.

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

Why Syneos Health

We focus on developing our people through career progression, supportive management, technical and therapeutic area training, peer recognition, and a total rewards program. Our Total Self culture fosters authenticity, where everyone is encouraged to be themselves. We celebrate diversity of thought, background, and culture, making Syneos Health a place where everyone feels they belong.

Job Responsibilities

Provide statistical programming leadership and support across clinical trials, ensuring compliance with project specifications and regulatory requirements.
Develop ADaM datasets, TLFs (Tables, Listings, and Figures), and SDTM datasets in alignment with study and sponsor requirements.
Lead the programming of statistical analyses and ensure timely delivery of datasets and outputs.
Review and provide feedback on programming documentation, ensuring accurate and efficient implementation.
Work closely with Biostatistics and other teams to resolve programming discrepancies and improve quality.
Develop and maintain programming specifications, ensuring that requirements are met for clinical trials.
Mentor junior programmers and provide guidance on complex programming issues.
Collaborate with project teams to deliver high-quality programming solutions within agreed timelines.
Contribute to the development and improvement of programming processes, tools, and techniques.
Participate in sponsor meetings and serve as a statistical programming expert for the project.
Ensure all programming and deliverables meet quality standards and inspection readiness.

Qualifications

What We’re Looking For:

Bachelor’s degree in a scientific, mathematical, or technical discipline; or equivalent experience.
Extensive experience with ADaM, TLFs, and SDTM datasets in a clinical trials environment.
Strong proficiency in SAS programming, with a solid understanding of statistical analysis and clinical trial processes.
Experience with regulatory submission standards and SDTM/ADaM specifications.
Excellent written and verbal communication skills.
Strong attention to detail, problem-solving abilities, and a proactive approach to programming tasks.
Ability to work independently and as part of a team in a fast-paced environment.

Get to Know Syneos Health

In the past five years, Syneos Health has worked with 94% of all Novel FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites with 675,000+ trial patients.

We encourage initiative and are constantly challenging the status quo in a competitive, ever-evolving environment. Learn more about Syneos Health and the difference we’re making in 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 needed. 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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Senior Principal Statistical Programmer (Adam, Tlf's, Sdtm)

Job Description

Job Description

Why Syneos Health

Job Responsibilities

Qualifications

Get to Know Syneos Health

Additional Information

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