Job Description

Senior Clinical Statistical Programmer - Women on Career Break

Senior Programmer (4-6 Yrs)

- The Senior Programmer acts as a support for Company\'s clinical trials, accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and Company\'s / industry standards.

Responsibilities:

- Plan and manage programming activities across multiple studies to deliver all data analysis outputs to agreed timelines and quality, (e.g., analysis datasets, tables, figures and listings for regulatory submissions and publications).

- Oversee outsourced tasks to third party vendors to meet the agreed timelines, quality and budget requirements established for the project or study.

- Implement data standards within a function, or therapeutic area in accordance with industry standards

- Responsible for programming and QC across a study/asset including submission activities adhering to relevant SOPs / policies.

- Participate in the design of other study delivery components (e.g. case report forms, study databases).

- Review and input into key study documents (e.g. SAP, CRF etc).

- Develop broader technical knowledge and expertise (e.g. UNIX scripting, computing environments).

- Provide technical advice, mentoring and training as relevant.

- Identify recurring problems and work with colleagues to initiate process improvement

Basic qualifications:

- Bachelor\'s Degree in engineering, Biotechnology, Computer Applications or related disciplines

- More than 2 years\' experience in SAS programming (including SQL and SAS macro language)

- Proficient in SAS programming and SAS macro code development.

- Effective written and verbal communication skills.

Preferred qualifications:

- Knowledge of other SAS modules (e.g. SAS/GRAPH, SAS Output Delivery System).

- Knowledge of non-SAS programming packages/languages (e.g. Spotfire, S-Plus, R)

- A good level of understanding of the pharmaceutical regulatory and reporting processes (e.g. 21 CFR Part 11).

- Working knowledge of CDISC data standards, primarily the creation and use of ADaM datasets

- Experience of interacting with clinical study team members

- Ability to learn and apply advanced programming skills independently

- Ability to manage conflicting demands and priorities

- Experience of the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g., working with/for CROs, academic institutions)

Details:

- If you have strong ambition, solid technical skills and passion for innovation and global-working, and you want to make a difference to patients\' lives then you could be the future of Company\'s Quantitative Sciences India (QSI) department, based in Bangalore.

- We are GlaxoSmithKline Asia Pvt Ltd, a world-leading Healthcare company with a mission to help people Do more, Feel better, Live longer. More than a billion patients use our products every day and we improve hundreds of millions of lives through the Sustainable Living Plan.

- Our Statisticians and Programmers belong to an established and large department of Company\'s that has built a strong reputation over its almost 20 year\'s heritage. With strong leadership, rich talent and high energy levels, our staff achieve their goals both professionally and personally. They play key roles on therapeutically aligned, cross functional and global teams, supporting the design, analysis and reporting of clinical trials. The roles are diverse, exciting and rewarding and training opportunities are plentiful. There are even possibilities for International travel.

- We have a number of ambitious goals to achieve in 2017, including a move to brand new state-of-the-art premises situated in the heart of Bangalore, and a significant expansion to grow the department.

IIM Jobs