Principal Statistical Programmer
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25002690
Estimated Salary: ₹2,500,000 - ₹3,500,000 per annum (based on industry standards for senior clinical/statistical programming roles in India)
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 look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work 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 to change lives.
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 total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture unites us globally, and we are dedicated to taking care of our people.
We continuously build the company we all want to work for and our customers want to work with. When we bring together diverse thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels like they belong.
Job Responsibilities
Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets as specified in statistical analysis plans and programming specs.
Ensure outputs meet quality standards and project requirements.
Perform validation programming and collaborate with programmers, biostatisticians, and team members to resolve discrepancies.
Keep project team members informed about programming progress and issues.
Follow applicable SOPs, work instructions, and regulatory guidelines (e.g., ICH).
Maintain organized, complete, and up-to-date project documentation, testing, and quality control records to ensure inspection readiness.
Manage scheduling and timelines across multiple projects, setting priorities and adapting workload as needed.
Develop dataset and output specifications according to sponsor and statistical requirements, anticipating potential issues to minimize rework.
Conduct effective internal meetings, distribute information timely, follow up on action items, and maintain meeting focus.
Collaborate and assist with projects and initiatives as needed to support business goals.
Ensure on-time delivery across concurrent programming tasks; negotiate timelines and provide risk mitigation plans.
Lead statistical programming activities, directing other programmers and monitoring deliverable progress.
Review project documentation (e.g., Statistical Analysis Plan, mock shells, programming specs) and provide constructive feedback.
Participate in sponsor meetings, kickoff meetings, and bid defenses as programming representative.
Mentor programming personnel by developing and delivering training, reviewing work, and providing guidance to new associates.
Maintain strong knowledge of clinical drug development, industry standards, and electronic submission requirements; serve as a technical expert.
Collaborate with biostatistics and programming teams to establish SOPs, guidelines, and procedures.
Develop programming tools and macros to improve standardization and efficiency.
Serve as a subject matter expert for CDISC and regulatory requirements; provide guidance, training, and compliance reviews.
Actively participate in industry standards organizations and update the department on changes.
Manage deliverable transfers.
Perform other related duties as assigned.
Minimal travel may be required.
Qualifications
Undergraduate degree preferably in a scientific or statistical discipline, or equivalent experience combined with demonstrated programming skills.
Extensive experience in SAS or other programming software in clinical trials, with leadership of complex/global projects.
Knowledge and experience with CDISC standards and regulatory agency submissions preferred.
Experience mentoring others in clinical trial processes and CDISC standards.
Excellent written and verbal communication skills.
Proficiency in English (reading, writing, speaking, understanding).
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’ll take initiative and challenge the status quo in a highly competitive and evolving environment.
Additional Information:
Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other duties at its discretion. Equivalent experience and qualifications may be considered. This description complies with all applicable legislation and company policies.
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
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