Principal Statistical Programmer

Flex and Oncology Clinical Research Private Limited; Ernakulam; On-site; INR 8,729,000 - 12,609,000; Full time

Job summary

Worldwide Clinical Trials is seeking an experienced Senior Statistical Programmer to lead the programming function's operating systems and provide technical and project consultancy across the Biostatistical Operations department.

You will manage multiple complex studies, drive CDISC standards implementation (SDTM, ADaM, Define.XML, CRT), and deliver high-quality statistical programming solutions while mentoring team members and ensuring timeliness and quality in sponsor deliverables.

Qualifications

• Advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS.
• Experience with regulatory submissions.
• 8+ years of related experience.

Responsibilities

• Lead and own multiple complex studies, managing sponsor expectations and coordinating with Biostatistical Operations leadership to ensure delivery timelines.
• Lead large study teams to deliver activities on time and with quality while maintaining team harmony.
• Drive the implementation of CDISC standards across studies (SDTM/ADaM/Define.XML/CRT) and design/validate SAS-based delivery processes.
• Provide expertise on regulatory submission requirements and mentor team members across the department.
• Support statistics reporting through specification of tables, figures, and listings, and ensure documentation and validation are maintained.

Skills

SAS programming

SAS/Macro

Proc Report

ODS

SAS/Graph

Proc SQL

SAS/STAT

Leadership

Regulatory submission

CDISC standards

Education

University Degree

Tools

Define.XML

CDISC standards

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.

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.

Join us!

SUMMARY:

To perform the principal programming role, lead and own continuous improvement in the programming function's operating systems and provide both technical and project consultancy across the function.

RESPONSIBILITIES:

• Lead and take full accountability for multiple complex studies (including submissions, integration projects) directly controlling sponsors expectation and working with Biostatistical Operations leadership team to maintain resource and ensure delivery deadlines met.
• Lead large study teams, ensuring all planned activities delivered to time and quality, whilst maintaining team harmony and motivation.
• Manage and organize competing priorities whilst displaying flexibility for change.
• Take ownership of quality and process improvement initiatives and diverse project tasks to meet detailed department and sponsor requirements.
• Use advanced understanding and experience of implementing CDISC standards across multiple studies (including SDTM / ADAM / Define.XML / CRT components).
• Use advanced knowledge of SAS, and alternate technical solutions to design and deploy Biostatistical delivery process improvements.
• Provide expertise and consultancy on regulatory submission requirements.
• Provide leadership and development of team members across the department.
• Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, writing of derived dataset specifications and the formatting of report documents and tabulations.
• Ensure the maintenance of documentation e.g. the description of programs and validation.
• Lead development and maintenance of in-house programming standards in line with quality standards and regulations.
• Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation.
• Assist with Quality Assurance and Audit requirements.
• Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).
• 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. The job holder must have a depth of expertise across all statistical programming skills and consistently display a positive attitude and considered as a global role model. Expert in upstream (Data Management) and downstream ((Medical Writing) processes.

REQUIREMENTS:

University Degree is required (post-graduate degree is preferable, but not mandatory). Minimum 8 years of previous related experience. 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. 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.

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. Not finding the right fit?