Senior Statistical Programmer 1

Flex and Oncology Clinical Research Private Limited; Ernakulam; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Worldwide Clinical Trials in India is seeking a Senior Statistical Programmer to lead SAS programming for CDISC SDTM/ADaM datasets and TFL outputs. You will mentor junior staff and collaborate with statisticians, data managers and external clients to ensure regulatory compliance.

The role requires advanced SAS skills (SAS/Macro, ODS) and 4+ years of related experience. Candidates should be prepared to work on complex studies and ensure quality and timely delivery.

Qualifications

• Advanced SAS programming skills including SAS/Macro, Proc Report and ODS.
• Strong SAS/Graph, Proc SQL and SAS/STAT knowledge.
• Experience providing programming leadership on complex studies.

Responsibilities

• Develop, test and execute SAS programs to produce CDISC SDTM/ADaM datasets, tables, figures and listings (TFL).
• Lead programming efforts on complex studies, coordinating with clients and internal teams.

Skills

SAS programming

SAS Macro

Statistical programming

Project leadership

Education

Bachelor's degree or equivalent

Tools

SAS

Job description

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

SUMMARY

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

RESPONSIBILITIES

Some team members may focus on a limited number of these responsibilities depending on requirements.

• 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 Reviewer's Guide) for high complexity studies.
• Serve as a programming project lead on a complex study (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.
• Contribute to department process improvement including creating and testing standard SAS Macros, maintaining the required validation documentation.
• Provide 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 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.
• Ensure all activities performed by the study team are 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).
• Act as a mentor for junior department members.
• Perform other duties as assigned.

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.

REQUIREMENTS

• Educated to degree level or equivalent.
• The jobholder has advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS.
• Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT.
• Minimum 4 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.

The company reserves the right to amend this job description in consultation with the employee to reflect changes in its organisational structure or to the job itself in line with emerging business needs.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status or other class protected by applicable law.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.