Job highlights

- Develop regulatory standards knowledge in computer systems,systems validation,Good Clinical Practice,clinical data management,clinical / statistical reporting and regulatory submission requirements etc
- The job holder must be computer literate and numerate with a willingness to adapt to various computer systems
- Minimum 6 years of previous related experience

Job Summary To perform the lead programming role, lead continuous improvement in the programming function's operating systems and provide consultancy across the function.

Responsibilities

- Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL).
- Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures and listings (TFL) shells.
- Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.g. patient profiles, OPS reports.
- Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewers Guide) for high complexity studies.
- Apply advanced knowledge of CDISC standards and electronic data submission (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewers Guide, Analysis Results Metadata).
- Provide expertise and consultancy on FDA, PMDA and other regulatory agencies submission requirements.
- Serve as a programming project lead on multiple complex studies (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively.
- Ensure budget and scope of project work remain aligned.




- Manage the study documentation flow as per Worldwide SOP and other procedural documentation including timely document submission to eTMF.
- Be able to describe and explain Worldwide documentation and eTMF requirements.
- Actively seek, propose and lead process improvement initiatives including development of standard SAS Macros, in-house programming standards.
- Participate in development of department SOPs, guidelines, templates and other quality management documentation.
- Provide training and consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements.
- Develop and provide Statistical Programmers, Biostatisticians and representatives of other departments and groups with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer.
- Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g. Excel, Visual Basic, Word).
- Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical Practice, clinical data management, clinical/statistical reporting and regulatory submission requirements etc.
- Act as subject matter expert for internal and external quality audits and inspections.
- Perform review of study proposals and budgets.
- Assist at bid defense and other sponsor meeting.




- Ensure all activities are performed by the study team in compliance with Worldwide and sponsor quality requirements, relevant ICH and regulatory authority standards, e.g. FDA 21 CFR Part 11, General Data Protection Regulation (GDPR).
- Provide training on the standards and requirements.
- Act as a mentor for the members of Biostatistical Operations department.
- Perform other duties as assigned.
- The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Other Skills and Abilities
- The job holder must be computer literate and numerate with a willingness to adapt to various computer systems.
- Hands-on expert level project statistical programmer experienced in providing programming leadership to projects.
- Statistical programming skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.
- It is essential that the job holder to possess strong analytical skills and attentiveness to detail.
- To have the ability to train new staff.

Requirements

- Educated to degree level or equivalent.
- The jobholder has advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS.
- Positive working knowledge in SAS/Graph, Proc SQL, SAS/STAT.
- Minimum 6 years of previous related experience.
- Promotion to the next level is not automatic based on years of experience.
- Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Statistical Programmer 2 (Kochi)
🏢 Worldwide Clinical Trials
📍 Kochi