Lead SDTM Programmer
3 weeks ago
Department: Study Data Tabulation Model Programming & Submission
Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.
About the department
Global Business Service (GBS), Study Data Tabulation Model Programming & Submission team was established in April 2016 and became a separate department in July 2021. The team has a good blend of experience and fresh perspective and comprises experienced SDTM Subject Matter and Submission experts, who form the core of the team. The main purpose & objective are to ensure high-quality compliant submission-ready SDTM packages in close collaboration with our stakeholders across the clinical landscape, for all clinical trials within Novo Nordisk.
The Position
The Lead Study Data Tabulation Model Programmer holds a pivotal role in ensuring adherence to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Documentation Practice (GDP), and Good Programming Practice (GPP) within the organization. Recognized as a key figure in supporting end users, the Lead SDTM Programmer operates independently while aligning with the strategic objectives of standards governance bodies and the company at large. Additionally responsible for resolving methodological or technically demanding tasks, where innovation serves as a critical element. This multifaceted position requires a blend of technical proficiency, strategic vision, and effective communication skills to ensure the smooth functioning of data management processes and uphold regulatory compliance standards.
Ensure design for clinical trials is aligned across trials within projects. Create the Study Data Tabulation Model (SDTM) submission package and post it to the publishing environment. Must have presented at conferences (within and outside India) and have a strong network within the pharmaceutical industry. Should have experience driving cross-functional initiatives with diverse stakeholders. Should have strong interpersonal capabilities to lead projects and people.Qualifications
Bachelors or Master in life sciences, natural sciences, pharmacy, veterinary science, engineering, clinical information management, computer science, or equivalent qualifications Minimum 6-8 years of experience in the Life Sciences industry and preferably 4 years within Clinical Data Management and with hands-on experience in Clinical Data Interchange Standards Consortium (CDISC) SDTM. Expert knowledge of end-to-end clinical data management activities and computer systems involved in clinical data management. Experience with programming languages, eg. SAS, R, Python, AI/ML Extensive experience with collaboration across professional and regional borders. Experience with communication and presentations. Experience in mentoring. Participation in conferences/workshops. Demonstrated experience with project management and stakeholder management. Profound knowledge of GxP and guidelines within drug development and regulatory activities.About Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life-changing.
-
Senior SDTM Programmer
1 month ago
bangalore, India Novo Nordisk AS Full timeDepartment: SDTM Programming & Submission Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we...
-
Senior SDTM Programmer
3 weeks ago
bangalore, India Novo Nordisk AS Full timeDepartment: SDTM Programming & Submission Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we...
-
Senior SDTM Programmer
4 weeks ago
bangalore, India Novo Nordisk AS Full timeDepartment: SDTM Programming & Submission Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we...
-
Lead SDTM Programmer
4 weeks ago
bangalore, India Novo Nordisk Full timeDepartment: Study Data Tabulation Model Programming & Submission Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your...
-
Sr Principal Stats Programmer
3 weeks ago
bangalore, India CSS Fortrea Scientific Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Programmer
1 month ago
bangalore, India Phastar Full timeTHE COMPANYPhastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics,...
-
Senior Principal Statistical Programmer
3 weeks ago
bangalore, India CSS Fortrea Scientific Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Principal Statistical Programmer
3 weeks ago
bangalore, India CSS Fortrea Scientific Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Principal Statistical Programmer
2 months ago
Bangalore, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Principal Statistical Programmer
3 weeks ago
Bangalore, India MUM Fortrea Development India Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Principal Statistical Programmer
2 months ago
bangalore, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Principal Statistical Programmer
3 weeks ago
bangalore, India MUM Fortrea Development India Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Programmer
1 month ago
bangalore, India Phastar Full timeTHE COMPANY Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics,...
-
Senior Principal Statistical Programmer
2 months ago
Bangalore, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Principal Statistical Programmer
3 weeks ago
bangalore, India MUM Fortrea Development India Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Principal Statistical Programmer
2 months ago
bangalore, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Senior Principal Statistical Programmer
3 weeks ago
Bangalore, India MUM Fortrea Development India Pvt Ltd Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Statistical Programmer 2
1 month ago
Bangalore, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Statistical Programmer 2
4 weeks ago
bangalore, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
-
Programming Lead
2 months ago
Bangalore, India Fortrea Full timeAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...
