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4 Efficacy Analysis Jobs

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4.0 - 8.0 years

0 Lacs

hyderabad, telangana

On-site

As a Statistical Programmer working fully embedded within one of our pharmaceutical clients, you will be at the heart of our client's innovation, with the support of Cytel right behind you. You will be dedicated to one of our global pharmaceutical clients, contributing to the advancement of patient treatment and working with autonomy and ownership. This role presents an exciting opportunity to be a part of a new program. Your responsibilities as a Statistical Programmer will include: - Performing data manipulation, analysis, and reporting of clinical trial data using SAS programming - Creating and validating datasets/analysis files, tables, listings, and figures (TLFs) with SAS programming skills - Generating complex ad-hoc reports - Preparing and validating submission packages - Applying strong understanding/experience in Efficacy analysis - Taking on lead duties when required - Being a team player, willing to go the extra mile to achieve results and meet deadlines - Demonstrating adaptability and flexibility when priorities shift To be successful in this position, you should have: - At least 4+ years of statistical programming experience in the clinical development environment - A BA/BSc or higher degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related scientific field - Proficiency in SAS data manipulation, analysis, and reporting - Familiarity with the drug development life cycle and experience in handling clinical trials data - Ability to work effectively in a globally dispersed team with cross-cultural partners - Strong oral and written English communication skills - Capability to deliver quality output within challenging timelines - Willingness to learn and adhere to company processes and procedures - Proficiency in complex statistical programming tasks - Ability to provide guidance to team members on technical and process questions Preferred qualifications include: - In-depth knowledge of SAS Graph and other SAS Statistical packages - Previous experience in publication work At Cytel, we prioritize our employees" success by offering consistent training, development, and support to ensure you thrive in your role.,

Posted 5 days ago

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8.0 - 12.0 years

9 - 15 Lacs

remote, india

On-site

We are seeking a Principal Biostatistician with a strong background in efficacy analysis to join our team. The ideal candidate will have extensive experience in creating and validating CDISC-compliant datasets , developing statistical analysis plans, and producing high-quality mock tables, listings, and figures. This role requires a detail-oriented professional with excellent communication skills who can manage multiple projects and collaborate effectively with cross-functional teams. Must-Have Skills Hands-on experience with efficacy analysis. Ability to manage multiple projects and meet tight deadlines. Excellent communication and collaboration skills. Good to Have Skills Proficiency in CDISC standards , particularly ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model) . Experience in creating and validating ADaM datasets to ensure they are analysis-ready and compliant with regulatory requirements. Hands-on experience with the creation of statistical analysis plans (SAPs) and mock TLFs (Tables, Listings, Figures) . Soft Skills Excellent communication skills for collaborating with cross-functional teams and presenting findings. Strong attention to detail and problem-solving abilities. Ability to manage multiple projects and meet deadlines.

Posted 3 weeks ago

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6.0 - 10.0 years

0 Lacs

hyderabad, telangana

On-site

You are a highly skilled Senior SAS Programmer sought to support statistical programming activities for clinical trials. Your responsibilities include end-to-end SAS programming for analysis and reporting, ensuring regulatory compliance, data standards, and high-quality deliverables. Your expertise in efficacy analysis, SDTM and ADaM generation, and TLF programming is crucial for this role. You will manipulate, analyze, and report clinical trial data using SAS, generating and validating SDTM and ADaM datasets in adherence to CDISC standards. Additionally, you will create and validate Tables, Listings, and Figures (TLFs) for study reports and regulatory submissions. Your role involves developing complex ad-hoc reports from raw clinical data and applying a deep understanding of efficacy analyses and clinical endpoints. Contribution to the preparation and review of submission documents and eCRTs is expected, as well as production programming and quality control to ensure accuracy and consistency. As a team player, you will commit to quality and meeting project deadlines, remaining adaptable and flexible in a fast-paced clinical environment. Qualifications required include a Bachelors or Masters degree in Life Sciences, Statistics, Computer Science, or a related field, along with 6+ years of hands-on experience in clinical trial programming using SAS. Proficiency in CDISC standards, Base SAS, SAS Macros, SAS/STAT, and SAS/GRAPH is essential. Experience in generating datasets and outputs for regulatory submissions and familiarity with eCTD standards are preferred. Strong attention to detail and analytical problem-solving skills are necessary for this role. Join a collaborative team environment where your expertise in clinical data programming directly contributes to advancing global healthcare. Precision, integrity, and innovation are valued in every project undertaken.,

Posted 1 month ago

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6.0 - 10.0 years

0 Lacs

karnataka

On-site

We are seeking a skilled Statistical Programmer with a strong background in R Programming to become a valuable addition to our expanding team. This remote position is ideal for individuals who are enthusiastic about clinical data analysis and programming, particularly those with a deep understanding of CDISC standards. As a Statistical Programmer, your main responsibilities will include developing, validating, and managing SDTM, ADaM datasets, and TLFs in compliance with CDISC guidelines. You will be conducting efficacy analyses using R programming, working autonomously on studies, and providing support for clinical trial submissions. Collaboration with various teams in an FSP environment will be crucial, along with efficient debugging and utilization of standard macros. If you have experience with integrated summaries (ISS/ISE), it is considered a plus. The ideal candidate should possess 6 to 8 years of relevant experience in statistical programming, with a minimum of 3 years of hands-on experience in R programming. A strong working knowledge of CDISC standards such as SDTM, ADaM, and TLF is essential, along with exposure to efficacy analysis. Senior-level profiles should have experience in handling studies at the study level. Preferred skills for this role include familiarity with the CRT package (Trial Data Domain), previous involvement in ISS and ISE, experience in an FSP environment, and proficiency in standard macro debugging and utilization. In return, we offer a bootstrapped and financially stable environment with an above-industry renumeration package. Additional compensation is tied to Renewal and Pilot Project Execution, along with lucrative business development incentives. Our organization provides opportunities for firm building and holistic professional development, emphasizing empathy, excellence, and results. We believe in mentoring and nurturing our team members, with a continuous focus on learning and growth.,

Posted 1 month ago

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