Senior/Principal Statistical Programmer

Job Title - Senior/Principal Statistical Programmer

Functional Area- Statistical Programming

Education Requirements - BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, Data science, life science or related field

Technical Skills Requirements

· Knowledge in programming languages such as SAS, basics of R etc.

· Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures).

· Good knowledge of industry standards, including CDISC data structures like SDTMs, ADaMs etc. and an understanding of developing and utilizing standard programs.

· Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions.

Experience requirements

· Minimum 5-15 years of work experience in a SAS programming role preferably supporting clinical trials or in pharmaceutical industry.

· Good knowledge of SAS with proven skills in statistical programming, including developing and validating deliverables.

· Demonstrated ability in communication and negotiation, collaborating effectively with others.

· Experience in leading programming team for a study.

· Ability to produce timely and quality deliverables under guidance.

Responsibilities

· Lead statistical programming activities as Study Lead for phase I to IV clinical studies or assigned project-level activities, ensuring adherence to project standards, regulatory guidelines and statistical methods.

· Keep up-to-date knowledge of programming software (e.g. SAS) as well as industry standards (e.g. CDISC SDTM/ADaM, Define.xml), participate in functional meetings and training.

· Co-ordinate programming activities of all programmers assigned to the study/project work, either internally or externally. Provide statistical programming recommendations and propose strategies at study level.

· Provide input on statistical programming solution and/or ensure their efficient implementation.

· In consultation with Statistician, responsible for developing programming specifications of analysis datasets.

· Ensure timely and quality development and validation of datasets (SDTM, ADaM) and outputs for various study/project milestone such as CSRs, regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) following specifications and statistical analysis plan.

Responsibilities

· Collaborate with cross-functional teams, capable of summarizing and discussing the status of deliverables and key programming aspects (such as timelines and scope), Act as Statistical programming representative in study-level team.

· Create CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies, ensuring adherence to project specifications and regulatory guidelines (e.g. FDA, EMA).

· Maintain comprehensive documentation of programming procedures, validation activities, and statistical analyses for regulatory submissions and audits.

If interested, kindly share your resume at [email protected] with following information and we ll get back to you for further discussion on it:

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