Associate Statistical Programmer

1 week ago

Hyderabad, Telangana, India Statistics & Data Corporation (SDC) Full time
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 basic SDTM datasets, safety listings, and safety tables, for clinical trials.

Primary Responsibilities

• Perform assigned statistical programming required for clinical trial analysis and reporting.

• Work under the direction of senior statistical programmers in completing clinical trial programming tasks.

• Assist in programming and validation of less complex CDISC SDTM and ADaM datasets.

• Generate safety listings and tables per protocol, Statistical Analysis Plan.

• Participate in statistical program validation and quality control activities, as assigned.

• Apply appropriate statistical methods for data analysis.

• Develop define.xml and create table of contents of programs for regulatory submissions.

• Assist in the review of study documents, programs and reports.

• 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. Timely completion of assigned tasks.

• 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.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

Required Skills

• Sound analytical skills, with the ability to process scientific and medical data.

• Basic SAS programming skills required, with working knowledge in SAS/BASE and SAS Macros.

• Exposure in manipulating and analyzing data.

• Ability to identify data issues, present problems, and implement solutions.

• Problem-solving skills.

• Able to work with minimal supervision.

• Good organizational and time management skills.

• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines

• (FDA/CFR, ICH/GCP).

• Strong interpersonal communication and presentation skills

Education or Equivalent Experience

Bachelor's degree in computer science, statistics or other related, scientific field.

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 a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.

• 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.

Take a look at how you can join our team

#LI-Hybrid

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