Principal Statistical Programmer (PSP)

Biostatistics · Bangalore, Karnataka
Department Biostatistics
Employment Type Full Time
Minimum Experience Experienced

About Novotech 


Novotech is the Asia-Pacific CRO designed for biotech, accelerating clinical development via cutting-edge technology to improve patient lives.

Working in a fast-paced and adaptable environment, we strive to set the benchmark for both business and clinical trial performance across all clinical trial phases and therapeutic areas.

Our people are critical in meeting organizational, and client objectives and we place a strong emphasis on creating a collaborative, transparent, and inclusive work environment where everyone is supported to achieve.


About the position 


Due to continued growth, we are looking for a talented Principal Statistical Programmer to join the Biometrics team in Bengaluru, India.


The purpose of the role is to develop and standardize program code for the purpose of undertaking data validation, and for generating tables, listings and figures (TLFs) which are part of interim and final reports, in accordance with applicable regulatory guidelines and using validated statistical software environments, in particular SAS.

The Principal Statistical Programmer (PSP) is primarily responsible for all statistical programming aspects, and/or acts as Lead Programmer, across several studies and will act as the Statistical Programming Coordinator and may provide ongoing supervision of an assigned portfolio of projects to ensure timely and efficient completion of projects


Core responsibilities:


• Provide input into statistical analysis plans with respect to presentation of data and results (tables, listings, figures) and advise project staff with requirements in relation to data collection, storage and tabulation (CDASH, SDTM, ADaM)
• Develop and validate SAS programs for the tabulation of data, preparation of subject listings, graphical output and statistical analysis of data.
• Develop and validate SAS programs for multivariate data checking of CRF and Non-CRF (external) data by Data Management
• Develop and maintain a library of validated programs based on CDISC (CDASH, SDTM, ADAM), and regulatory guidance for data submissions, in particular FDA.
• Act as Project Programmer for assigned projects involving multiple studies, and ensure consistency in data structuring and presentation
• Act as mentor to junior statistical programmers and conduct training activities 
• Assist clinical data management in developing clinical databases and eCRF’s for data capture and cleaning that are compliant with CDASH/CDISC requirements.


Minimum Qualifications & Experience:


  • Minimum Bachelor’s Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or in Quantitative/Analytical field.
  • A minimum 8 years of experience in pharmaceutical industry, CRO or related experience using SAS programming in clinical studies including leading a clinical study or project programming team. Able to independently perform technical work and oversee a statistical project programming team. Exceptional SAS programming skills; contribute programming to a global library of macros.
  • Advanced knowledge of CDISC standards and applying standards to different study phases, study designs and therapeutic areas.


Find out more about working at Novotech at: www.novotech-cro.com/careers


Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. 


Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.


We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.


We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

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  • Location
    Bangalore, Karnataka
  • Department
    Biostatistics
  • Employment Type
    Full Time
  • Minimum Experience
    Experienced