Senior Statistical Programmer
Location: Kolkata, India
Job ID: R1451479
Employment Type: Full Time
Job Overview:
The Senior Statistical Programmer will develop statistical methods for clinical protocols, review CRFs, prepare analysis plans, and generate specifications for analysis files, tables, and figures. The role includes client communication, study execution, data interpretation, and mentoring junior staff, with a focus on quality, efficiency, and revenue optimization.
Essential Functions:
Production of High-Quality Deliverables:
Completes and reviews complex tasks ensuring accuracy and SOP compliance.
Validates data processing, checks programming logs, and manages data issue logs.
Leadership:
Acts as statistical lead on individual studies.
Collaborates with Project Team Lead to ensure timely, budget-conscious, high-quality deliverables.
Leads meetings, maintains customer relationships, and drives statistical discussions.
Supports EAC (Estimate at Completion) reporting.
Data Management:
Reviews database design, validation checks, and critical data.
Resolves data issues and oversees lock/unblinding process in lead role.
Statistical Analysis Plan (SAP) and Shells:
Authors or QCs SAPs and shells using organizational tools and resources.
Handles complex SAPs under supervision when necessary.
Datasets & TLFs (Tables, Listings, and Figures):
Writes and maintains programming specifications and derives datasets to standards.
Programs and reviews TLFs ensuring consistency and adherence to specifications.
Timelines & Financials:
Plans resources, documents timelines, and raises scope issues.
Shares budget accountability and flags potential rework or scope creep.
Knowledge Sharing & Mentorship:
Trains and mentors junior programmers.
Motivates and supports team members.
Risk Management:
Identifies project risks early and implements mitigation strategies.
Study Startup & Protocol Support:
Assists in protocol development and CRF review.
Authors/QCs statistical sections of protocols.
Client Interaction & Proposals:
Occasionally acts as client POC and contributes to RFPs and bid defenses.
Lock and Unblinding Process:
Leads database lock and unblinding procedures.
May participate in randomization activities.
Other Responsibilities:
Performs cross-functional collaboration and ad-hoc tasks as assigned by managers.
Qualifications:
Education & Experience:
Bachelor’s in Biostatistics or related field + 7 years’ experience, OR
Master’s in Biostatistics or related field + 6 years’ experience, OR
Ph.D. in Biostatistics or related field + 5 years’ experience.
Typically requires 6+ years of relevant experience or equivalent education/training.
Skills & Knowledge:
Strong command of SAS and familiarity with nQuery or similar tools.
Advanced statistical and analytical problem-solving abilities.
In-depth understanding of GCP, ICH guidelines, and CDISC/ADaM standards.
Excellent organizational, communication, and writing skills.
Proven ability to lead teams and manage multiple projects effectively.
About IQVIA:
IQVIA is a global leader in clinical research, commercial insights, and healthcare intelligence. The company advances medical innovation and population health by fostering intelligent connections in the life sciences industry.
Apply Now: IQVIA Careers
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