Senior Statistical Programmer

1 week ago

Bengaluru, Karnataka, India Ergomed Full time
The Senior Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation. The Senior Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps.

Role and Responsibilities

- Maintains responsibility for all assigned duties within a clinical study, this may include:

- Ensuring that work is performed on time

- Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality

- Works with other biometrics' team members to represent the needs and input of the programming components of the study

- Program SDTM and ADaM datasets

- Create SDTM and ADaM specifications

- Create CDISC submission packages e.g. Define.xml and Reviewers Guide

- Program tables, listings, and figures in SAS from specifications

- Deliver training and mentorship to SP and other operational staff, as applicable

- Contribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related content

- Act as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topics

- Act as a program or sponsor lead across multiple studies, clinical programs, and/or large complex studies with responsibility for all statistical programming activities and ensuring consistency across multiple studies

- Develop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency

- Assist their manager with programming work projections to aid departmental planning

- Represent 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

- Excellent knowledge and understanding of SAS Base, Macro and ODS

Education

Bachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science.

- Extensive knowledge of SAS programming and statistical programming topics relevant to clinical trials including statistical analysis-based procedures and/or indication specific methods; may have expertise in one or more topics.
- Advanced CDISC knowledge
- Hands-on experience using P21E

Experience

Minimum of 10 years' of experience in developing derived datasets, TFL programming and submission packages in Clinical Research.

Special Skills

- Organization skills, including attention to detail and multitasking
- Communication skills

PC Skills

- Knowledge of the MS Office Suite
- Proficiency in one or more statistical programming languages (includes SAS, R)

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.

We offer:

- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join

- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
- We look forward to welcoming your application.
- #LI Remote

Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia

Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patient's lives.

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