Lead Statistical Programmer

1 day ago

kottayam, India beBeeStatistical Full time

Job Role OverviewWe are seeking a skilled Principal Statistical Programmer to join our team.Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs' needs.Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet the pre-specified timelines.Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.Participate in the development of CRFs, edit check specifications, and data validation plans.Provide review and/or author data transfer specifications for external vendor data.Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals.Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices.RequirementsProficient in SAS programming language and have experience in developing, validating, and maintaining SAS and/or R programs.Strong understanding of clinical trials process, including GCP and FDA regulations.Excellent analytical and problem-solving skills, with ability to work independently and collaboratively as part of a team.Effective communication and interpersonal skills, with ability to provide clear and concise technical guidance and support.Ability to prioritize tasks, manage multiple projects, and meet deadlines.Ability to maintain confidentiality and handle sensitive information with discretion.BenefitsOpportunity to work on diverse range of clinical development programs.Chance to collaborate with experienced professionals in the field.Professional growth and development opportunities.Competitive compensation package.What We OfferA dynamic and supportive work environment.The opportunity to contribute to the creation of high-quality statistical programming deliverables.Training and development opportunities to enhance your skills and knowledge.A collaborative and inclusive team culture.

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