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48 Bristol-Myers Squibb Jobs
Manager, Statistical Programming
4-9 years
₹ 16 - 20L/yr (AmbitionBox estimate)
Hyderabad / Secunderabad
1 vacancy
Manager, Statistical Programming
Bristol-Myers Squibb
posted 2d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Primarily responsible for quality and timely delivery of SDTM artifacts required for downstream activities and regulatory submissions.
- Review synopsis and/or protocol and provide comments for the Review Committee
- Design SDTM specification as per Company CDISC standards and ensure they meet downstream ADaM and Reporting requirements
- Understand different formats of data collection including CRF and non- CRF( external) data and the challenges involved in integration of the two sources into target SDTM model.
- Annotate CRFs and Review annotated CRFs in accordance with BMS guidelines and appropriate metadata to reflect tabulation datasets
- Oversee/ develop SAS programs to generate SDTM datasets
- Create and/or validate eCRT package for regulatory submission.
- Working knowledge of BMS SDTM automation tools, macros and metadata.
- Intricate understanding of clinical development life-cycle , stake-holder interactions and data interactions that aid in identification of issues root-cause.
- Maintain high quality of deliverables with validation and resolution of issues surfaced in Pinnacle21 and BMS Quality tools and ensure the quality meets regulatory submission standards.
- Collaborate with stakeholders and Study team members to manage study timelines, and resolve issues and escalate if necessary.
- Ensure that all programming deliverables are compliant with CDISC
- Partner with CROs and act as a primary point of contact for SDTM programming activities
- Provide oversight of CRO/vendor programming activities to ensure adherence of standards as well as receiving quality and timely deliverables
- Receive, process and review datasets, as well as data review reports from CROs
- Ensure that programming best practices are adhered to by both CRO and BMS programmers
- Participate in study/project team meetings as a core member and provide technical expertise/support.
- BA/BS in a relevant scientific discipline with 4 plus years Pharmaceutical/CRO experience as a SAS Programmer supporting clinical trials for regulatory submissions with expertise in CDSIC/SDTM.Experience Requirements
- Minimum of 4 years clinical/statistical programming experience within pharmaceutical clinical development
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Employment Type: Full Time, Permanent
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Anonymous · Pharmaceutical & Biotechnology
in Hyderabad
Compensation and benefits are quite good. The health related benefits are better than other employers.
There is no growth and learning as there is no career ladder. Employees in US treats Indians as slave and assign work that is of no visibility to us. They take credit of our work and show it on global portal. For future growth discussions managers comment on the current compensation and says we are paying you better so do what is ass..Read More
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