Senior Statistical Programmer

Job Title: Senior Statistical Programmer

Location: India (Remote) / Hybrid (Open to Pune / Hyderabad)

We are experiencing exponential growth on a global scale and hiring Senior Statistical Programmers to join our FSP division. You will apply your know-how in CDISC standards (SDTM & ADaM) and advanced SAS programming skills, to support or lead one or more Phase I-IV clinical trials, across a variety of therapeutic areas.

Our values

• We believe in applying scientific rigor to reveal the full promise inherent in data.
• We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
• We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
• We prize innovation and seek intelligent solutions using leading-edge technology.
• As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.

How you will contribute:

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
• Generating and validating analysis datasets/analysis files, and complex tables, listings, and figures ( TLFs)
• Production and QC / validation programming
• Generating complex ad-hoc reports utilizing raw data and analysis datasets
• Applying strong understanding/experience of Efficacy analysis
• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
• Performing lead duties for assigned clinical study under principle programmers oversight
• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Being adaptable and flexible when priorities change
• Generating and validating Non-CDISC transformation datasets and analysis datasets
• Proficient knowledge with SDTM/ADaM and TLF’s. General expertise with Figures
• Individuals should be able to start programs from scratch and have the ability to handle complicated domains and outputs related to the protocol and SAP.
• They must demonstrate a good understanding of the endpoints and data collection, with the ability to read and write specifications related to the respective implementation guides.
• R & complex macro writing are a plus

What you offer:

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
• At least 5+ years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
• Study lead experience, preferably juggling multiple projects simultaneously.
• Strong SAS data manipulation, analysis and reporting skills.
• Strong QC / validation skills.
• Good ad-hoc reporting skills.
• Solid ADaM and complex TFL skills.
• Proficiency in efficacy analysis and survival analysis
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
• Submissions experience utilizing define.xml and other submission documents
• Excellent analytical & troubleshooting skills.
• Ability to provide quality output and deliverables, in adherence with challenging timelines.
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.