Senior Manager, Statistical Programming

3 weeks ago

Durham, United States SHATTUCK LABS, INC. Full time
Job DescriptionJob Description

About the position:

Responsible for the statistical programming function at Shattuck Labs to ensure statistical integrity, adequacy and accuracy of clinical studies/databases and to deliver high quality data package within the agreed upon timelines. Perform statistical programming and data analyses in the support of product development including IND/ CTA submissions. Help to select, coordinate and manage external vendors supporting statistical programming. Maintain and improve professional knowledge of technological advancements in data manipulation and statistical analyses. Train and manage staff (internal, contract, CRO) to support the statistical programming team as the organization grows.

  • Engage with clinical teams and served as the lead statistical programmer for clinical studies. Review statistical analysis plan and shells for tables, figures and listings. Write, test and validate SAS programs to perform statistical analyses to analyze and report clinical trials data in table, listings and figures. Write or review SDTM and ADaM dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed). Perform ad hoc and exploratory statistical analyses as needed.
  • Lead Quality Check activities to ensure high quality data output delivery.
  • Provide oversight and supervision of relevant external consultants and clinical research organizations for outsourced statistical programming activities. Manage CROs to analyze and report complex data in table, listings and figures, and for electronic submission of SDTM and ADaM in CDISC format.
  • Ensure systems are in place to produce quality work efficiently. Evaluate workloads, resources, process, and technology, and prioritize projects/deliverables for efficient operation of the statistical programming function.
  • Development of standard SAS programs, and standard statistical programming operating procedures as needed.
  • Engage in regulatory submission as needed. Participate in the preparation of publications including manuscripts, posters and oral presentations.

Qualifications/requirements:

  • 6+ years industry experience with Phase I to IV clinical trial data in biostatistics and statistical Programming; ability to efficiently manage several programs and protocols
  • Working experience in CDISC standards including SDTM and ADaM data standards, creating define files, cSDRG, ADRG and oncology specific domains in SDTM, previous regulatory submission with CDISC package is preferred.
  • Proficiency in SAS programming language.
  • Management experience including managing QC process, external vendors/partners.
  • A Master’s degree in Statistics or other related field with high statistical content.
  • Experience in oncology clinical trials including hematological malignancy and solid tumor.
  • Experience in PK data analysis including preparation of data for NONMEN analysis is preferred.

Additional skills/traits:

  • Proficiency with SAS and other programming skills.
  • Good communication and interpersonal skills and ability to work with cross-functional teams.
  • Positive and collaborative attitude.
  • Unrelenting dedication to delivering high quality results.
  • Experience in statistical programming for oncology clinical trials.
  • Deeply motivated self-starter with an entrepreneurial spirit.
  • Good team player.
  • Ability to work in a quickly changing, fast-paced environment, and to adapt and adjust to changing priorities.
  • Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently.

  • Statistical Programmer 4

    3 weeks ago

    Durham, United States ACL Digital Full time

    schedule: M-F core hours being 10-3 EST with some flexibility - must be 8 hours a day/40 hours week Working in a Team of: 4-7 Personality style: Looking for someone who is proactive and engaging. Not afraid to ask questions. Candidate Introvert/Extrovert: Extroverted - will have client contact How will performance be measured: Project reviews and progress...

  • Senior Program Manager

    21 hours ago

    Durham, United States Digital Turbine Full time

    Senior Program Manager Durham, NCAMER – Engineering Ops /Full-time /HybridAt Digital Turbine , we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers — intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and...

  • Senior Program Manager

    3 weeks ago

    Durham, United States Avalara Full time

    Overview: Avalara is hiring a Senior Program Manager to join our Corporate Program Management Office (PMO).?The Corporate PMO leads programs shaped around our most strategic growth and efficiency projects. Our program are recognized for their judicious structure, ownership, and ability to guide clarity and understanding while guarding results.Are you ready...

  • Senior Technical Program Manager

    2 weeks ago

    Durham, North Carolina, United States Digital Turbine Full time

    As a Senior Technical Program Manager, you'll be responsible for leading new releases of our flagship products into market. You'll be responsible for collaborating across Development, Product and Marketing teams to ensure releases are successfully planned, executed and delivered. To be successful in this role, you'll need to have a strong grasp of...

  • Senior Technical Program Manager

    1 month ago

    Durham, North Carolina, United States Digital Turbine Full time

    As a Senior Technical Program Manager, you'll be responsible for leading new releases of our flagship products into market. You'll be responsible for collaborating across Development, Product and Marketing teams to ensure releases are successfully planned, executed and delivered. To be successful in this role, you'll need to have a strong grasp of...

  • Senior Technical Program Manager

    3 weeks ago

    Durham, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers - intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs supercharge...

  • Senior Technical Program Manager

    2 weeks ago

    Durham, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers - intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs supercharge...

  • Senior Technical Program Manager

    3 weeks ago

    Durham, North Carolina, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers — intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs...

  • Senior Technical Program Manager

    2 weeks ago

    Durham, North Carolina, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers — intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs...

  • Senior Technical Program Manager

    2 weeks ago

    Durham, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers - intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs supercharge...

  • Senior Technical Program Manager

    2 weeks ago

    Durham, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers - intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs supercharge...

  • Senior Product Manager

    2 weeks ago

    Durham, United States Blue Cross and Blue Shield of North Carolina Full time

    **Senior Product Manager - Pilot Program** Location Durham, North Carolina, United States of America Category Other JOB DESCRIPTION As a health care company, we believe that vaccines are the best way to move past the COVID-19 pandemic. We also want to provide our employees with as much autonomy and choice as possible. Employees can choose where they work...

  • Senior Program Manager – PMO

    2 weeks ago

    Durham, United States Intelliswift Software Full time

    Job Title: Senior Program Manager – PMODuration: 3 Months Possibility of extensionLocation: Durham, NC/HybridIntelliswift Software Inc. conceptualizes, builds, and supports the world's most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT...

  • Senior Program Manager – PMO

    3 weeks ago

    Durham, United States Intelliswift Software Full time

    Job Title: Senior Program Manager – PMODuration: 3 Months Possibility of extensionLocation: Durham, NC/HybridIntelliswift Software Inc. conceptualizes, builds, and supports the world's most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT...

  • Senior Program Manager – PMO

    2 weeks ago

    Durham, United States Intelliswift Software Full time

    Job Title: Senior Program Manager – PMODuration: 3 Months Possibility of extensionLocation: Durham, NC/HybridIntelliswift Software Inc. conceptualizes, builds, and supports the world's most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT...

  • Senior Program Manager – PMO

    2 weeks ago

    Durham, United States Intelliswift Software Full time

    Job Title: Senior Program Manager – PMODuration: 3 Months Possibility of extensionLocation: Durham, NC/HybridIntelliswift Software Inc. conceptualizes, builds, and supports the world's most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT...

  • Senior Technical Program Manager

    2 weeks ago

    Durham, NC, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers — intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs...

  • Senior Technical Program Manager

    3 weeks ago

    Durham, NC, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers — intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs...

  • Program Development Analyst

    2 days ago

    Durham, United States VeeAR Projects Full time

    Deliverables: Meet with management regarding progress toward goals; provide status updates. - Bi-Weekly Provide a monthly report of completed, pending, and projected action items. - Monthly Engage stakeholders and partners ( administrative officers, Office of Communications, Web Team, Senior Leadership, etc.) to ensure satisfactory completion of project...

  • Senior Scientific Program Leader

    1 month ago

    Durham, United States Duke University Full time

    School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding le Program Leader, Leader, Clinical Research, Senior, Programmatic, Public Health, Healthcare