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Job Overview: We are seeking a dedicated Senior Statistical Programmer to join our dynamic team. You will be responsible for the development, quality control, and documentation of statistical (SAS) programming deliverables for clinical research studies.
Key Responsibilities:
1. Lead and oversee the development of SAS programs for the management and statistical analysis of clinical trial data.
2. Develop, test, and validate statistical tables, listings, and graphs (TLGs) in support of the statistical analysis plan.
3. Support the generation and review of protocols, data management plans, study reports, and other regulatory documents.
4. Provide input to the statistical analysis plan, table shells, data integration plans, and mock-ups.
5. Ensure data quality by designing and validating key data checks and listings.
6. Develop specifications for derived datasets and perform data transformation as necessary.
7. Collaborate effectively with data management and biostatistics teams, clinicians, and other project stakeholders.
8. Guide junior programmers and provide mentoring as needed.
9. Keep abreast of new developments in SAS programming and clinical research, and act as a subject matter expert for the team.
Required Qualifications and Skills:
1. Bachelor's or master’s degree in Statistics, Mathematics, Computer Science, or a related field.
2. Minimum of 3 plus years of statistical programming experience in the pharmaceutical, biotech, or CRO industry.
3. Excellent SAS programming skills and proficiency in SAS/Base, SAS/Macro, SAS/Graph, and SAS/STAT.
4. Familiarity with CDISC SDTM and ADaM data standards.
5. In-depth understanding of clinical trial data and extremely complex statistical methods.
6. Excellent problem-solving skills and a proactive approach to identifying and resolving issues.
7. Strong written and verbal communication skills, with the ability to translate complex data into understandable results.
8. Proficiency in English, with excellent written and verbal communication skills.
9. Prior experience leading teams or projects is highly desirable.
Preferred Skills:
1. Experience in oncology, immunology, respiratory, infectious diseases, or neurosciences is a plus.
2. Knowledge of other statistical software such as R or Python is a plus.
3. Knowledge of regulatory guidelines (FDA/EMA/ICH) is preferred.
In this role, you will:
As part of a team focused on the preserving the customer experience across the organization, this Analytic Consultant will be responsible for:
- Understand business objectives and provide credible challenge to analysis requirements.
- Verify sound analysis practices and data decisions were leveraged throughout planning and data sourcing phases.
- Conduct in-depth research within complex data environments to identify data integrity issues and propose solutions to improve analysis accuracy.
- Applying critical evaluation to challenge assumptions, formulate a defendable hypothesis, and ensuring high quality analysis results.
- Ensure adherence to data management/ data governance regulations and policies.
- Performing and testing highly complex data analytics for customer remediation.
- Designing analysis projects flow and documentation that is structured for consistency, easy to understand, and to be offered to multiple levels of reviewers, partners, and regulatory agents demonstrating research and analysis completed.
- Investigate and ensure data integrity from multiple sources.
- Ensure data recommended and used is the best “source of truth”.
- Applies knowledge of business, customers, and products to synthesize data to 'form a story' and align information to contrast/compare to industry perspective. Data involved typically very large, structured or unstructured, and from multiple sources.
- Must have a strong attention to detail and be able to meet high quality standards consistently.
- Other duties as assigned by manager.
- Willing to assist on high priority work outside of regular business hours or weekend as needed.
Essential Qualifications:
- Around 5+ years in similar analytics roles
- Bachelors, M.A./M.Sc. College Degree or Higher in applied mathematics, statistics, engineering, physics, accounting, finance, economics, econometrics, computer sciences, or business/social and behavioral sciences with a quantitative emphasis.
- Preferred programming knowledge SQL/SAS
- Knowledge of PVSI, Non-Lending, Student Loans, Small Business and Personal Lines and Loans is a plus.
- Strong experience with data integration, database structures and data warehouses.
- Persuasive written and verbal communication skills.
Desired Qualifications:
- Certifications in Data Science, or BI Reporting tools.
- Ability to prioritize work, meet deadlines, achieve goals and work under pressure in a dynamic and complex environment – Soft Skills.
- Detail oriented, results driven, and has the ability to navigate in a quickly changing and high demand environment while balancing multiple priorities.
- Ability to research and report on a variety of issues using problem solving skills.
- Ability to act with integrity and a high level of professionalism with all levels of team members and management.
- Ability to make timely and independent judgment decisions while working in a fast-paced and results-driven environment.
- Ability to learn the business aspects quickly, multitask and prioritize between projects.
- Exhibits appropriate sense of urgency in managing responsibilities.
- Ability to accurately process high volumes of work within established deadlines.
- Available to flex schedule periodically based on business need.
- Demonstrate strong negotiation, communication & presentation skills.
- Demonstrates a high degree of reliability, integrity and trustworthiness.
- Takes ownership of assignments and helps drive assignments of the team.
- Dedicated, enthusiastic, driven and performance-oriented; possesses a strong work ethic and good team player.
- Be proactive and get engaged in organizational initiatives.