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Sr Statistical Programmer

2+ years
Not Disclosed
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 Statistical Programmer
Updated: December 13, 2024
Location: India-Asia Pacific - IND-Home-Based, India
Job ID: 24006302

Job Description

Senior Statistical Programmer

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

Our Clinical Development model puts the customer and the patient at the heart of everything we do. We’re continually looking for ways to simplify and streamline our operations to make Syneos Health easier to work with and a better place to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers and innovators to help our customers achieve their goals. We are agile, driven, and committed to accelerating 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 are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and a comprehensive rewards program. Our Total Self culture unites us globally, fostering authenticity and creating a place where everyone feels like they belong.

Job Responsibilities

  • Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets as outlined in the statistical analysis plan and programming specifications.
  • Ensure outputs meet quality standards and project requirements.
  • Perform validation programming and collaborate with other programmers, biostatisticians, and project team members to resolve discrepancies or findings.
  • Keep team members informed of programming progress and issues requiring attention.
  • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
  • Maintain well-organized, complete, and up-to-date project documentation, testing, and verification/quality control documents, ensuring inspection readiness.
  • Manage scheduling and time constraints across multiple projects, adapt to changing priorities, and reorganize workload to meet deadlines.
  • Develop specifications for datasets and outputs of any complexity according to statistical and sponsor requirements.
  • Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for others’ opinions.
  • Conduct effective internal meetings, distribute relevant information, ensure prompt distribution of minutes, and follow action items through to completion.
  • Display willingness to work with others and assist with projects and initiatives as necessary to meet business needs.
  • Negotiate accurate time estimates for study programming activities and complete them within the agreed timeframe.
  • Lead statistical programming activities, directing the programming efforts of other personnel and monitoring progress.
  • Review project documentation such as the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design, providing feedback to reduce inefficiencies.
  • Participate in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative.
  • Contribute to mentoring programming personnel through training courses, presenting materials, reviewing work, and guiding new associates.
  • Transfer deliverables and perform other work-related duties as assigned.
  • Minimal travel may be required.

Qualifications

What We’re Looking For:

  • Undergraduate degree, preferably in a scientific or statistical discipline; or an equivalent combination of education and programming experience.
  • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment.
  • Excellent written and verbal communication skills.
  • Proficiency in reading, writing, speaking, and understanding English.

Get to Know Syneos Health

Over 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 challenge the status quo in a highly competitive, ever-evolving environment. Learn more about Syneos Health and the difference we’re making in the world of biopharmaceuticals.

Additional Information

The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may, at its discretion, assign other tasks or responsibilities. Equivalent experience, skills, and/or education will also be considered. All job descriptions are intended to comply with applicable legislation and promote equal opportunities in recruitment and employment practices.