Senior Statistical Programmer
Updated: May 21, 2025
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002685
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 that we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
Whether joining us in a Functional Service Provider partnership or a Full-Service environment, you will 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.
Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
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.
Committed to our Total Self culture – where you can authentically be yourself. This culture unites us globally and we dedicate ourselves to taking care of our people.
Continuously building a company where diversity of thought, backgrounds, cultures, and perspectives come together, creating a place where everyone feels like they belong.
Job Responsibilities
5-8 years of experience in SDTM / ADaM / TFLs. Develop and validate SDTM/ADaM datasets and TFLs. Support safety and efficacy analyses.
Contribute to e-submission activities by generating define.XML, ADRG/SDRG, and leading clinical study trials.
Use SAS or other software to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in statistical analysis plans and programming specifications.
Ensure outputs meet quality standards and project requirements.
Perform validation programming and collaborate with programmers, biostatisticians, and project team members to resolve discrepancies or findings.
Keep project team members informed of programming progress and issues requiring attention.
Follow applicable SOPs, work instructions, and relevant regulatory guidelines (e.g., ICH).
Maintain organized, complete, and up-to-date project documentation, testing, and quality control documents ensuring inspection readiness.
Manage scheduling and time constraints across multiple projects, set goals based on management priorities, and adapt to changes by reorganizing daily workload.
Develop dataset and output specifications of any complexity according to statistical and sponsor requirements; anticipate and address potential programming issues to minimize rework.
Prepare for and contribute ideas during internal meetings; respect opinions of others and maintain meeting focus.
Demonstrate willingness to assist with projects and initiatives as needed to meet business needs.
Negotiate and establish accurate time estimates for study programming activities and complete work within agreed timeframes.
Act as lead statistical programmer, directing activities of other programmers and monitoring deliverables.
Review project documentation including Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs; provide feedback to improve efficiency.
Participate as statistical programming representative in sponsor meetings, kickoff meetings, and bid defense meetings as required.
Mentor programming personnel through training development, material presentation, work review, and guidance of new associates.
Transfer deliverables in a timely manner.
Perform other duties as assigned.
Minimal travel may be required.
Qualifications
Graduate or Post Graduate degree, preferably in scientific or statistical discipline; or equivalent combination of education and demonstrated programming experience.
Extensive programming experience in SAS or other relevant software, preferably in a clinical trial environment.
Excellent written and verbal communication skills.
Ability to read, write, speak, and understand English.
Salary Estimate
₹15,00,000 - ₹25,00,000 per annum (depending on experience and location within India)
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 your role, you will take initiative and challenge the status quo in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information:
Tasks, duties, and responsibilities listed are not exhaustive. The company reserves the right to assign other duties as needed. Equivalent experience, skills, or education may be considered in lieu of stated qualifications. Nothing herein creates an employment contract. The company complies with legislation including the EU Equality Directive and Americans with Disabilities Act, providing reasonable accommodations as appropriate.
Slug: senior-statistical-programmer-syneos-health-india
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