Principal Stat Programmer

0-2 years

Not Disclosed

India

10 March 24, 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

Principal Stat Programmer

Updated: March 19, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002254

Description

Principal Statistical Programmer
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into real-world outcomes. Our Clinical Development model brings the customer and patient to the center of everything we do.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help 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 invest in career development and progression.
Supportive and engaged line management.
Technical and therapeutic area training.
Peer recognition and total rewards programs.
A culture where you can authentically be yourself.

Job Responsibilities:

Develops custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets.
Ensures outputs meet quality standards and project requirements.
Performs validation programming and resolves discrepancies with team members.
Keeps project teams informed of programming progress and issues.
Adheres to applicable SOPs, WIs, and regulatory guidelines (e.g., ICH).
Maintains well-organized, complete, and up-to-date project documentation.
Manages scheduling across multiple projects, setting goals based on management priorities.
Develops specifications for datasets and outputs, addressing potential programming issues.
Conducts effective internal meetings, distributing relevant information in advance.
Ensures on-time delivery across concurrent programming deliverables.
Acts as the lead statistical programmer, directing programming activities of other team members.
Reviews project documentation such as Statistical Analysis Plan, programming specifications, and annotated CRFs.
Participates in sponsor meetings and bid defense meetings as required.
Mentors programming personnel by developing training courses and reviewing work.
Serves as a technical expert for CDISC standards and regulatory requirements.
Performs compliance reviews for CDISC deliverables, including SDTM and ADaM specifications.
Participates in industry standards organizations and provides updates on changes.
Transfers deliverables and performs other assigned duties.
Minimal travel may be required.

Qualifications:

Undergraduate degree, preferably in a scientific or statistical discipline; or equivalent combination of education and demonstrated programming experience.
Extensive programming experience in SAS or other software, preferably in a clinical trial environment.
Knowledge and experience in CDISC Standards and regulatory agency requirements.
Experience in regulatory submissions preferred.
Experience mentoring others in clinical trial processes and CDISC Standards.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.

Additional Information:

Tasks, duties, and responsibilities listed are not exhaustive and may be changed at the company’s discretion.
Equivalent skills, experience, and education will be considered.
The company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations when necessary.

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Principal Stat Programmer

Job Description

Description

Job Responsibilities:

Qualifications:

Additional Information:

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