Senior Clinical Data Programmer chez Calyx

We’re on a mission to change the future of
clinical research. At Perceptive, we help the
biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but to do this, we need people like you.

Apart from job satisfaction, we can offer you:

HEALTH:

- Medical plan for you and your dependents.

- Personal Accident Insurance

- Life Insurance

- Critical illness cover

WEALTH:

- Salary structure and Flexi basket

- Provident fund of 12%

- Gratuity scheme

YOURSELF: Internal growth and development programs & trainings

As a Senior Clinical Data Programmer, your core responsibility is to understand complex business requirements and identify strategic opportunities to drive efficiency and value through data. Leverage advanced programming languages, scripts, and software tools to perform sophisticated data extraction, transformation, and validation, ensuring the highest standards of data integrity and consistency across critical projects.

Key Accountabilities:

Programming (Data Engineering)

• Architect and maintain complex programs, ensuring robust data integrity and accuracy.

• Create advanced programs for generating detailed reports and summaries of clinical trial data.

• Design and implement advanced software to ensure data handling and reporting meet stringent regulatory standards.

• Ensure data quality and integrity through rigorous validation and quality control processes.

• Identify, analyze, and resolve complex database issues to ensure seamless operation and data flow.

• Generate complex reports by finding, selecting, acquiring and ingesting data sources utilizing established tools and methods.

• Develop sophisticated automation tools to streamline repetitive tasks, improving efficiency and reducing errors.

• Performs Code reviewes and introduces best practices

• Support data setup (eCRF) desig if needed

• Seeks specialist security knowledge or advice when required to support own work or work of immediate colleagues.

Data Quality Assurance

• Maintain the highest standards of data accuracy, integrity, and consistency.

• Performs careful analysis of data to produce clear findings

• Detect and verify basic data issues to ensure accuracy and reliability of data and analysis.

• Evaluate data to confirm it meets the requirements for its intended purpose.

• Analyze and understand the context in which data is utilized to ensure relevance and applicability.

• Ensure programs and data handling procedures comply with stringent regulatory standards

• Exhibit a proactive and analytical mindset by asking relevant questions and thoroughly investigating data-related problems.

• Execute data preparation and cleansing tasks with precision, following established guidelines and best practiceswith guidance.

Data Management

• Data Governance – Highlight the critical role of data governance in maintaining data integrity, security, and compliance within the organization. Ensure that all data activities adhere to established policies and regulatory requirements to protect sensitive clinical data and uphold ethical standards.

• Focus on enhancing data accuracy, accessibility, and actionable insights. Implement project-specific strategies to ensure that data is collected, stored, and analyzed efficiently, supporting the overall goals of clinical research.

Data Operations

• Support business stakeholders in generation of reports to support efficient business process and outlier reviews

• Ability to interpret concepts, ideas and data to outputs that are understood by the business.

• Independently identify gaps/issues/trends through exploratory data analysis

• Use discussions with stakeholders and understanding of existing available data to pull and provide data driven insights to the business from various systems.

Documentation

• Participate in review of export requirements specification and external, client documentation

• Document evidence of data findings following internal SOPs and best practices

• Create installation qualification documents and other technical specifications that provide instructions for program execution.

• Contribute to creation and maintenance of documentation for all programming activities and processes.

Other

• Seeks specialist security knowledge or advice when required to support own work or work of immediate colleagues.

• Carries out any other reasonable duties as requested.

Functional Competencies (Technical knowledge/Skills)

• Knowledge of clinical vocabulary and healthcare data standards.

• Demonstrable understanding of relevant ICH-GCP Guidelines, local regulatory requirements and SOPs and study specific procedure.

• Significant demonstrable knowledge and understanding of clinical trial data systems, regulatory requirements, and industry standards - CDISC (CDASH/SDTM/ADaM) mapping/specs/conversion/domains/dataset desirable.

• Understanding of clinical trial protocols and case report forms.

• Comprehensive knowledge of Good Clinical Practice: In-depth understanding of clinical trial design and the overall drug development process.

• Strong advanced analytical and problem-solving skills to address complex data-related issues.

• Strong logical reasoning and structured problem-solving skills.

• Ability to approach complex problems methodically and develop effective solutions in a fast-paced, time-sensitive and dynamic environment.

• Advanced analytical thinking, attention to detail: Ensure high-quality results with a focus on accuracy and precision.

• Robust time management and prioritization skills to meet objectives and timelines.

• Proven ability to work collaboratively within a matrix team environment.

• Communicates fluently, orally and in writing, and can present complex information to both technical and nontechnical.

• Ability to swiftly understand new technologies and processes - quickly adapt to and integrate new technologies and methodologies with a knowledge sharing approach.

• Ability to manage multiple and varied tasks: enthusiastically handle multiple tasks and prioritize workload with meticulous attention to detail.

• Maintains an awareness of developing practices and their application and takes responsibility for driving own development.

• Demonstrated ability to apply critical thinking to complex problems and tasks.

• Proactive participation in skills improvement.

• Demonstrated evidence of accountability relative to key accountabilities in the job description.

Experience, Education, and Certifications

• Significant professional experience in the same or very similar role.

• Extensive experience and proficiency using computer languages to extract and analyse data.

  • PL/SQL, Python – required.

  • SAS (SAS Macros, PROC SQL), R, JavaScript.

  • .Net

• Experience with big data technologies and tools.

• Familiarity with clinical trial protocols and case report forms.

• Experience using tools to communicate progress to Stakeholders.

• Bachelor's Degree in a technical discipline (Math, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience.

• English: Fluent.

Come as you are.

We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.