Job Title: Senior Principal Statistical Programmer
Job Summary
We are hiring a Senior Principal Statistical Programmer to join our global healthcare team in Hyderabad. This pivotal role will lead asset and trial programming teams, develop and validate clinical datasets, and provide expert statistical programming solutions across therapeutic areas such as Oncology, Neurology, and Fertility. Ideal candidates should have 9+ years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO sectors, along with proficiency in SAS, R, CDISC SDTM, and ADaM standards.
Key Responsibilities
Lead trial or asset programming teams as the Lead Statistical Programmer.
Ensure timely and quality delivery of statistical programming activities for global clinical assets.
Develop SDTM and ADaM datasets, including specifications, Define.xml, and reviewer's guides.
Design and validate analytical outputs based on the Statistical Analysis Plan (SAP).
Generate datasets for integrated summaries such as ISS and ISE.
Perform ad-hoc programming activities as per internal and external stakeholder requirements.
Contribute to process improvements, innovation initiatives, and knowledge sharing within statistical programming.
Provide expert guidance, mentorship, and training to junior programmers and cross-functional teams.
Required Skills & Qualifications
BSc or MSc in Mathematics, Statistics, Computer Science, or related field.
Minimum of 9 years’ experience in clinical statistical programming within pharma, biotech, or CROs.
Proficiency in SAS and R programming languages.
In-depth understanding of CDISC SDTM and ADaM standards.
Experience with Define.xml creation and review processes.
Familiarity with clinical development processes and global regulatory submission standards.
Ability to solve complex programming challenges and optimize solutions.
Strong leadership, communication, and mentoring abilities.
Perks & Benefits
Opportunity to work on global clinical development programs.
Access to cutting-edge statistical tools (SAS, R, Shiny).
Professional growth and career advancement within a global healthcare organization.
Inclusive and diverse work environment.
Comprehensive employee benefits (details not specified).
Company Description
A global leader in Healthcare, Life Science, and Electronics, the company pioneers innovative medical solutions to improve and extend lives worldwide. The organization fosters scientific curiosity, diversity, and inclusion to drive excellence in patient care.
Work Mode
On-site (Hyderabad, India)
Salary/Compensation
Not specified in the job description.
Call to Action
Ready to shape the future of clinical data programming and drive impactful healthcare solutions? Apply now to join a global leader in statistical programming and clinical development.
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