Principal Statistical Programmer

SDC (Statistics & Data Corporation); Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Benefits offered by this job

Flexible Work Schedule

Career Advancement Opportunities

Employee Recognition Program

Engaging Work Culture

Fun Activities from Culture Club

Job summary

Join a forward-thinking organization that specializes in delivering top-tier clinical trial services. This role offers the opportunity to provide statistical programming support, develop SAS datasets, and ensure quality in clinical data management. As part of a diverse team, you will engage in meaningful work that contributes to the development of life-saving medicines. With a commitment to employee growth and a vibrant company culture, this position is perfect for those passionate about making a difference in the healthcare industry. Embrace the chance to innovate and grow in a supportive environment that values integrity and collaboration.

Qualifications

• 8+ years of experience in statistical programming and data analysis.
• Strong SAS programming skills with proficiency in various SAS modules.

Responsibilities

• Provide statistical programming support for clinical trials and data analysis.
• Lead design and development of SAS macros to expedite programming tasks.

Skills

Analytical Skills

SAS Programming

Problem-Solving Skills

Statistical Programming Knowledge

Communication Skills

Organizational Skills

Education

Bachelor's Degree in Computer Science or Statistics

Tools

SAS/Base

SAS/Stat

SAS Macros

SAS/Graph

Job description

Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.

Job Summary

Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.

Primary Responsibilities

• Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity.
• Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams.
• Review the Statistical Analysis Plan in preparation for programming the planned analyses.
• Lead design/development of SAS macros and other utilities to expedite SAS programming activities.
• Organize and conduct internal training sessions and author papers for conferences.
• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request.
• Participate in statistical program validation and quality control activities.
• Develop or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets.
• Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines.
• Develop define.xml, study data reviewers guide and analysis datasets reviewers guide.
• Identify study priorities and communicate effectively with project team and management.
• Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours.
• Manage statistical programming timelines, budgets, and client expectations.
• Actively participate in study team meetings.
• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects.
• Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management.
• Program data cleaning checks, as necessary, to assist Data Management's data cleaning activities.
• Participate in installation/validation of statistical software packages throughout the software development lifecycle.
• Develop and maintain the infrastructure for project files of SAS datasets and SAS code.
• Mentor junior level statistical programmers by developing training plans and providing oversight of their work. Ensure all programming activities and processes performed are conducted according to SDC's standard procedures and/or sponsor requirements.
• Adhere to all aspects of the SDC's quality system.
• Comply with SDC's data integrity & business ethics requirements.
• Perform other related duties incidental to the work described herein.
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements.

Requirements
Required Skills

• Strong analytical skills, with the ability to process scientific and medical data.
• Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, SAS Macros and SAS/Graph.
• Strong problem-solving skills.
• Able to work independently.
• Excellent knowledge of statistical programming.
• Proficient in manipulating and analyzing SAS data.
• Ability to identify data issues, present problems, and implement solutions quickly.
• Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues.
• Good organizational and time management skills, with the ability to multi-task.
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). Expert knowledge of CDISC SDTM and ADaM data models.
• Very strong interpersonal communication, presentation, and leadership skills.
• SAS Base, Advance and Clinical Trials Certification is preferred.

Education Or Equivalent Experience

Bachelor's degree in computer science, statistics or other related, scientific field and at least eight years of relevant professional experience; or an equivalent combination of relevant education and/or experience.

Benefits
Why SDC

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results.

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.