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Biostatistician: One of the leading lifescience company in India manjeet.kaur@mounttalent.com whatsapp at 8384077438 PAN India Experience Required : 7 12 Years of experience Job description: Deliver statistical expertise and knowledge to internal and external stakeholders. Understand research papers and implement in ongoing studies. Knowledge of latest trends in the statistical research in the clinical trials domain. Review and take responsibility for all the deliverables to external stake holders. Support programming team in understanding the concepts and provide solutions. Communicate between internal and external teams and different departments. Meet project timelines with quality Compliance to regulatory requirements. Provide department level trainings. Guide in preparing and presenting statistical papers in Indian and International conferences. Experience in designing the CRF and input to protocol. Experience in writing SAP/RAP, dataset specifications and mock shells. Knowledge on CDISC standards Review of tables, listings, figures and interpret the results Abale to write clinical study reports and statistical reports for submissions Experience in oncology and other major therapeutic areas Experience in programming in SAS/R Experience in handling submission studies, ISE and ISS. Being adaptable and flexible when priorities change. Strong QC/validation skills. Proficiency in efficacy analysis. Bachelors degree/ Masters/PhD in one of the following fields Statistics, Computer Science, Mathematics, etc.

Greetings from You & I Consulting! We've proudly helped candidates build careers at 64+ top MNCs across India, and were excited to bring you a new opportunity with a leading global company. If you have experience in Statistical Programming , this role is your next step forward! To Apply: Send your CV via WhatsApp or Call : Puja- (8250242229) or email your resume at :- puja@careersuni.com Shift - General Shift Open Locations :- Mumbai Pune Bangalore Hyderabad Indore Ahmedabad Key Responsibilities: Lead and oversee statistical programming activities for clinical trials at compound/indication/TA level Design and develop SDTM and ADaM datasets as per CDISC standards Generate Tables, Listings, and Figures (TFLs) for clinical study reports and regulatory submissions Manage and review deliverables for eSubmissions, including Define.xml and reviewer guides Provide technical leadership and mentorship to global programming teams Collaborate closely with biostatistics, data management, and regulatory affairs teams Support and lead Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) projects Ensure programming compliance with SOPs, FDA/EMA guidelines, and quality standards Required Qualifications: Bachelors or Masters degree in Statistics, Computer Science, or a related field 10+ years of SAS programming experience in clinical research or pharmaceutical industry Strong hands-on experience with ADaM, TFLs, eSubmissions, and integrated analysis Deep understanding of CDISC standards, regulatory compliance, and submission requirements Prior experience in oncology, neuroscience, or immunology domains preferred Proven leadership capabilities in managing cross-functional and global teams Excellent communication, project management, and problem-solving skills Preferred Tools & Skills: SAS (Base, Macro, STAT, Graph) Familiarity with SDTM/ADaM IG, FDA submission standards Understanding of regulatory submission formats (eCTD) How to Apply / Schedule an Interview: Send your details via WhatsApp or Call : Puja- (8250242229) in the following format: Full Name: Mobile Number: Email Address: Highest Qualification: Total Experience: Current Organization: Preferred Location: Current CTC: Expected CTC: Notice Period: Note: If the line is busy, please drop a WhatsApp message and we will get back to you at the earliest. Referrals Welcome! Know someone who fits the bill? Share this post and help them grow their career! You & I Consulting Your Career Growth Partner

Roles And Responsibilities: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timeframe Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate.

Roles And Responsibilities: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to enable successful project deliverables Review statistical analysis plans, mock-shells, database set-up specifications Validate or Review the Programming packages (includes the aCRFs, specifications and datasets, Define.XML and Reviewers Guides (for both SDTM and ADaM) Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables Develop innovative solutions to standardize, automate and optimized efficiency and quality Proactively addresses project uncertainties to minimize risk and alerts or escalates the issue to the appropriate person (project team member, lead biostatistician, or management), identifies, communicates, and overcomes technical and interpersonal obstacles Development and maintenance of tracking systems, folder systems and archival of analysis Contributes strategies that allow multi-tasking or efficient implementation to reduce execution time to meet deadlines in fast-paced environment Build a team of programmers to support ongoing pipeline expansion.

Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell Develop and/or validate SDTM domains and ADaM datasets as per the specifications for both Safety and efficacy Develop and/or validate Tables, Listings, and Figures using SAP and mock shells Create or review P21 reports, define packages [Define.xml] and Reviewers guide [RGs] for CDISC Data Standards Ability to work independently and as part of a team environment Provide the status of assigned tasks to the Study Lead Programmer Actively participating in the study meetings and support as backup lead Identify, communicate, and manage study-based risks and issues within the timeframe Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines Provide guidance, mentoring, and training for junior team members as appropriate Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as the accuracy and reliability of statistical analysis results To ensure that the assigned team members are in compliance with SOPs and training requirements.