Full-Time Senior Statistical Programmer
Ergomed is hiring a remote Full-Time Senior Statistical Programmer. The career level for this job opening is Expert and is accepting Bengaluru, India based applicants remotely. Read complete job description before applying.
Ergomed
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The Senior Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for creating SDTM/ADaM datasets and programming tables, listings, and figures (or other output), supporting and complementing biostatisticians on projects, and creating/maintaining appropriate documentation. The SP is accountable for the initial quality of the product (dataset or output) via thorough quality control steps.
Role and Responsibilities
- Maintains responsibility for all assigned duties within a clinical study, which may include:
- Ensuring work is performed on time
- Ensuring all created/reviewed content is appropriate, valid, relevant to the study, and high quality
- Working with other biometrics team members to represent the needs and input of the programming components of the study
- Programs SDTM and ADaM datasets
- Creates SDTM and ADaM specifications
- Creates CDISC submission packages (e.g., Define.xml and Reviewers Guide)
- Programs tables, listings, and figures in SAS from specifications
- Delivers training and mentorship to SPs and other operational staff (as applicable)
- Contributes to department development by supporting adherence to good programming and best practices (through training, macro development, standard process input/review, or other related content)
- Acts as a statistical programming expert and provides consultative support to internal programmers and biostatisticians on programming topics
- Acts as a program or sponsor lead across multiple studies, clinical programs, or large complex studies, responsible for all statistical programming activities and ensuring consistency across studies
- Develops innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency
- Assists manager with programming work projections to aid departmental planning
- Represents statistical programming in client or agency study audits
- Supports the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topics
Education
Bachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science
Experience
Minimum of 10 years' experience in developing derived datasets, TFL programming, and submission packages in Clinical Research.
Skills
- Strong organization skills, attention to detail, and multitasking
- Strong communication skills
- Proficiency in MS Office Suite
- Proficiency in one or more statistical programming languages (including SAS, R)
- Extensive knowledge of SAS programming and statistical programming topics relevant to clinical trials
- Advanced CDISC knowledge
- Hands-on experience using P21E