3.0 - 7.0 years

0 Lacs

telangana

On-site

Role Overview: As a Statistical Programmer II at Syneos Health, you will be part of a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our Clinical Development model prioritizes putting the customer and patient at the center of our work, aiming to simplify processes and innovate as a team to make a difference in people's lives. Key Responsibilities: - Utilize advanced proficiency in Base SAS, SAS Macro, and SAS SQL for clinical trial data analysis and reporting - Demonstrate in-depth knowledge of CDISC standards to develop ADaM specifications and datasets for regulatory submissions - Produce high-quality Tables, Listings, and Figures (TFLs) covering safety and efficacy endpoints - Experience in programming patient narratives is considered a strong asset - Prepare Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) for submission packages - Conduct Pharmacokinetics (PK) and Pharmacodynamics (PD) data analysis, including non-compartmental analysis and support for modeling activities - Preferred experience in Oncology, Neuroscience, and Immunology studies Qualifications Required: - 3-4.5 years of experience in statistical programming - Technical expertise in SAS Programming, ADaM Dataset Development, TFL Generation, and PK/PD Analysis - Background in Therapeutic Area Expertise with experience in Oncology, Neuroscience, and Immunology studies (Note: The job description may not be exhaustive and additional tasks, duties, and responsibilities may be assigned at the company's discretion. Equivalent experience, skills, and education will also be considered for the role.),

Posted 1 day ago

Apply

Medical Writer II (QC of Regulatory Docs) Syneos Health

2.0 - 6.0 years

0 Lacs

haryana

On-site

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, you will coordinate quality and editorial reviews, manage source documentation, and act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format of documents. In this role, you will interact with clients, department heads, and peers to produce high-quality writing deliverables. You will conduct online clinical literature searches, propose solutions to document issues, mentor less experienced medical writers, and maintain a strong working knowledge of drug development processes, regulatory guidelines, and industry best practices. The ideal candidate for this position should have a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and the AMA Manual of Style is desired. In this dynamic role at Syneos Health, you will have the opportunity to contribute to the development of innovative therapies and make a meaningful impact on patient lives. If you are passionate about translating clinical insights into tangible outcomes and thrive in a collaborative and fast-paced environment, we invite you to join our team and be part of a global organization committed to customer success and employee well-being.,

Posted 1 month ago

Apply

Senior/ Principal DSRM Writer (CSR/Patient Narratives) Siro Clinpharm

3.0 - 8.0 years

9 - 17 Lacs

mumbai suburban, navi mumbai, mumbai (all areas)

Hybrid

We have below job opportunity with SIRO Medical Writing Pvt Ltd. Role: Senior/ Principal - DSRM Writer (Narrative Writing) Location: Mumbai Hybrid OR Remote (only based out of Mumbai) Role & responsibilities Senior Writer, Reviewer and Project Manager to perform authoring, standalone QC, data QC and scientific review of all types of Narratives and other assigned medical writing documents Perform project management activities with effectively leading the Narrative Writing activities & build expertise across the different document types Compliance to timelines, quality, processes & policies and robust tracking of revenues, resource utilization and budget Preferred candidate profile Looking only for candidates with CSR/ Patient Narratives authoring/end-end writing experience ICSR/ PV Narratives candidates are NOT REQUIRED

Posted Date not available

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.