Katalyst CRO
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Statistical Programmer
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Katalyst CRO 1 month ago Be among the first 25 applicants Join to apply for the
Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Lead programming efforts for various clinical studies, from Phase 1 to Phase 3, across multiple therapeutic areas. Develop and review annotated Case Report Forms (CRFs) and SDTM datasets, ensuring accurate data representation. Program SDTM, ADaM, and TLFs, and write detailed dataset specifications. Perform quality control on datasets and tables, ensuring compliance with project requirements. Work closely with Clinical Operations, Clinical Data Management, Drug Safety, Regulatory Affairs, and Project Management teams to ensure the timely and accurate delivery of statistical programming work. Provide technical input on documentation produced by other functions, including biostatisticians, medical writers, and data managers. Ensure clear and effective communication regarding project progress, timelines, and any issues that may impact deliverables. Contribute to process improvement initiatives aimed at enhancing efficiency and quality in statistical programming. Identify new tools and technologies to optimize the programming workflow and improve deliverable quality. Serve as a mentor and role model, setting high expectations for quality, creativity, and ownership across projects. Manage competing priorities and foster a collaborative work environment to support project success.
Responsibilities
Lead programming efforts for various clinical studies, from Phase 1 to Phase 3, across multiple therapeutic areas. Develop and review annotated Case Report Forms (CRFs) and SDTM datasets, ensuring accurate data representation. Program SDTM, ADaM, and TLFs, and write detailed dataset specifications. Perform quality control on datasets and tables, ensuring compliance with project requirements. Work closely with Clinical Operations, Clinical Data Management, Drug Safety, Regulatory Affairs, and Project Management teams to ensure the timely and accurate delivery of statistical programming work. Provide technical input on documentation produced by other functions, including biostatisticians, medical writers, and data managers. Ensure clear and effective communication regarding project progress, timelines, and any issues that may impact deliverables. Contribute to process improvement initiatives aimed at enhancing efficiency and quality in statistical programming. Identify new tools and technologies to optimize the programming workflow and improve deliverable quality. Serve as a mentor and role model, setting high expectations for quality, creativity, and ownership across projects. Manage competing priorities and foster a collaborative work environment to support project success.
Requirements:
Master's degree in Statistics, Computer Science, Mathematics, Engineering, or a related field. 6 years of experience in clinical trial programming within the biotechnology, pharmaceutical, or healthcare industry. Expertise in SAS programming, with proficiency in additional statistical software such as R or S-Plus. In-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies. Strong organizational skills and the ability to prioritize and manage multiple tasks efficiently. Self-motivated, technically proficient, and able to work independently while maintaining a strategic perspective on statistical programming processes. Experience working with cross-functional teams to ensure project alignment and timely execution. Knowledge of process improvement strategies within statistical programming is a plus. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Statistical Programmer
role at
Katalyst CRO 1 month ago Be among the first 25 applicants Join to apply for the
Statistical Programmer
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Lead programming efforts for various clinical studies, from Phase 1 to Phase 3, across multiple therapeutic areas. Develop and review annotated Case Report Forms (CRFs) and SDTM datasets, ensuring accurate data representation. Program SDTM, ADaM, and TLFs, and write detailed dataset specifications. Perform quality control on datasets and tables, ensuring compliance with project requirements. Work closely with Clinical Operations, Clinical Data Management, Drug Safety, Regulatory Affairs, and Project Management teams to ensure the timely and accurate delivery of statistical programming work. Provide technical input on documentation produced by other functions, including biostatisticians, medical writers, and data managers. Ensure clear and effective communication regarding project progress, timelines, and any issues that may impact deliverables. Contribute to process improvement initiatives aimed at enhancing efficiency and quality in statistical programming. Identify new tools and technologies to optimize the programming workflow and improve deliverable quality. Serve as a mentor and role model, setting high expectations for quality, creativity, and ownership across projects. Manage competing priorities and foster a collaborative work environment to support project success.
Responsibilities
Lead programming efforts for various clinical studies, from Phase 1 to Phase 3, across multiple therapeutic areas. Develop and review annotated Case Report Forms (CRFs) and SDTM datasets, ensuring accurate data representation. Program SDTM, ADaM, and TLFs, and write detailed dataset specifications. Perform quality control on datasets and tables, ensuring compliance with project requirements. Work closely with Clinical Operations, Clinical Data Management, Drug Safety, Regulatory Affairs, and Project Management teams to ensure the timely and accurate delivery of statistical programming work. Provide technical input on documentation produced by other functions, including biostatisticians, medical writers, and data managers. Ensure clear and effective communication regarding project progress, timelines, and any issues that may impact deliverables. Contribute to process improvement initiatives aimed at enhancing efficiency and quality in statistical programming. Identify new tools and technologies to optimize the programming workflow and improve deliverable quality. Serve as a mentor and role model, setting high expectations for quality, creativity, and ownership across projects. Manage competing priorities and foster a collaborative work environment to support project success.
Requirements:
Master's degree in Statistics, Computer Science, Mathematics, Engineering, or a related field. 6 years of experience in clinical trial programming within the biotechnology, pharmaceutical, or healthcare industry. Expertise in SAS programming, with proficiency in additional statistical software such as R or S-Plus. In-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies. Strong organizational skills and the ability to prioritize and manage multiple tasks efficiently. Self-motivated, technically proficient, and able to work independently while maintaining a strategic perspective on statistical programming processes. Experience working with cross-functional teams to ensure project alignment and timely execution. Knowledge of process improvement strategies within statistical programming is a plus. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Statistical Programmer jobs in
Rockville, MD . Washington, DC $88,300.00-$220,900.00 1 month ago Washington, DC $88,300.00-$220,900.00 1 month ago Jr. Modeling & Simulation Analyst (TS/SCI)
Bethesda, MD $84,000.00-$117,000.00 2 weeks ago Annapolis Junction, MD $130,000.00-$270,000.00 2 days ago Reston, VA $60,000.00-$65,000.00 2 months ago Arlington, VA $50,000.00-$60,000.00 2 days ago Applied Data Scientist Internship (DoD SkillBridge)
Chevy Chase, MD $80,000.00-$185,000.00 3 days ago Engineering Analyst, Gemini and Labs, Trust and Safety
Washington, DC $147,000.00-$216,000.00 1 week ago Bethesda, MD $130,000.00-$216,000.00 2 weeks ago Columbia, MD $110,000.00-$119,000.00 20 hours ago Data Scientist: Cleared Talent Community - Virginia
Junior Data Scientist (Supply Chain & Weapons Production Networks)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr