Senior Statistical Programmer (Pharma/CRO, India)

Are you looking to join a company where your contributions truly matter, and where you’ll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Job Description

• Mastery in generating tables, listings, and graphs from clinical trial databases using SAS.

• Utilizes System Development Life Cycle (SDLC) for programming deliverables.

• Advanced user in SAS programming, SAS Base, and SAS Macros. •Advanced knowledge of E-Submission Standards, Guidelines and Regulations.

• Mastery and train on SDTM standards including ability to write specifications.

• Advanced knowledge of ADaM standards including supporting specification writing.

• Proficient with MS Office applications.

• Advance knowledge of ICH, 21CRF Part 11, and ISO 9001:2000 requirements.

• Advanced experience with pooling of data sets for submissions.

• Advanced experience with BIMO outputs, define.xml, Reviewer’s Guides, SDSP.

• Lead study or small programming project teams

• Independently manages tasks and projects to achieve set objectives. Provides guidance to more junior level colleagues.

• Identifies and suggests opportunities for improvement related to Service and/or Service Line at the project level and may contribute to improvements.

• Actively contributes ideas, suggestions and best practices in interactions with the external and internal customers. Frequently supports Business Development activities and customer kick off meetings.

• Experienced professional who knows how to apply theory and put it into practice with in-depth understanding of the professional field; independently performs the full range of responsibilities within the service; possesses broad job knowledge; analyzes problems/issues of diverse scope and determines solutions.

• Proactively stays abreast on external industry and technology developments; able to diagnose internal and customer gaps and propose relevant solutions.

• Maintains high level of confidentiality related to customer and internal projects.

• Exercises high degree of judgment regarding the information that can be disclosed internally and externally.

• Solves complex problems; takes a broad perspective to identify solutions.

• Produces high quality project deliverables across multiple, high complexity projects with high level of efficiency.

• Represent self and company in a professional manner and in line with core company values.

• Practice excellent internal and external customer service, communication, and team work.

• Support objectives and improvement efforts within department and organizationally.

• Comply with all applicable policies, procedures, and training requirements.

• Additional tasks as assigned by manager.

Minimum Requirements

• College graduate in computer science or related field required, Masters preferred, or related experience.

• 5-9 Years of prior programming experience preferred; interested in expanding knowledge of drug development as it pertains to programming.

• Has high level knowledge of drug development as it pertains to clinical programming; has the ability to apply drug development knowledge during production of high quality programs.

• Strong hands-on experience with clinical trials and pharmaceutical development.

• Strong experience with data and production of TLGs.

• Strong programming and logic skills.

• Thorough understanding of CDISC standards and HL-7 standards.

• Experience in pharmaceutical or CRO industry.

• Strong SAS programming, SAS Base, SAS Macro experience.

• Thorough knowledge of clinical database structures.

• Ability to program data presentations, using program such as SAS procedures.

• Excellent organizational and communication skills.