David Senne

Burdick, Ks ***** & Remote 620-***-**** ad0003@r.postjobfree.com linkedin.com/in/david-senne

Manager Principal Statistical Programmer

Over 16 Years Experience in the field of clinical research with proficiency as a skilled SAS programmer in the pharmaceutical sector, using SDTM and ADaM datasets, tables, listings, and figures. Experience with a successful NDA submission that included, eSub work, Pinnacle 21 and Define. Implement process improvement initiatives resulting in more efficient Oncology studies. Global expertise in managing a team for over 3 years. This included 7 programmers in South Africa and the United Kingdom.

Therapeutic Areas

Oncology Pain Therapeutics Rare Diseases Vaccines Respiratory Central Nervous System Pediatrics

Experience

Syneos Health - MORRISVILLE, NC 12/2020 – 09/2023

Manager Statistical Programming, 02/2023 - 09/2023

Manager, Statistical Programming – FSP Contract

Led studies with the Statistical Programming Lead and Statistician on ADaM and TLF requirements that included eSub package via Pinnacle 21 to complete the define.xml and cSDRG and ADRG. Simultaneously led 2 studies in Rare Disease line to ensure all mentoring and administrative duties were finished in a timely manner.

Ensured Statistical Programming department met timelines, provided high quality deliverables, complied with contractual project requirements and SOPS within budget.

Managed staff development, training and retention. Helped set career goals to develop skills.

Facilitated succession planning and maintained a staff with diverse skills, abilities, and competencies meeting the business needs of the Statistical Programming department.

Maintained a good working knowledge of clinical drug development, ICH, and other regulatory guidelines, and Statistical Programming.

Led or supported projects across multiple studies or programs, partnering with other departments such as Statistics, Clinical team, Data management and Medical Affairs.

Principal Statistical Programming Lead – FSP Contract, 12/2020 - 01/2023

Led studies with the Statistical Programming Lead and Statistician. All annual reporting was completed (e.g. DMC, IB and IND / DSUR). Along with annual reports (CSR, Dry runs). Addressed all ad hoc requests to meet the high standards of client procedures. Maintained a clean database working with Data Management and the Clinical Scientist to ensure all known significant data points were covered.

Onboarded SAS programmers for programming activities to validate key essential components of the clinical reporting and submissions work; screened candidates.

Served as primary company and client escalation point for study-related activities and personnel feedback.

Provided mentoring and leadership for the Biostat Programming Team and participated in all study-related activities to monitor communication / performance to ensure quality and efficient results.

DOCS Global - North Wales, PA – FSP Contract 08/2015 – 12/2020

Led studies by working with the Statistical Programming Leads, Statisticians, and Clinical Scientist in the Oncology therapeutic area in phases 1 – 4. Worked on ADaM / TLF production and QC as well as ADaM specifications and table shells. Narratives, Profiles and in-text tables were produced with assistance from the Medical Writer.

David Senne ad0003@r.postjobfree.com Page 2

Flex Project Lead, 8/2017 - 12/2020

Onboarded and trained SAS programmers to support clinical reporting and submissions work.

Screened and recruited candidates and maintained regular 1:1 meetings with team members and client to ensure client work was effective and all skills were up-to-date and served as primary point-of-contact.

Performed all administrative duties as the line manager to ensure financial details were met including time sheets, PTO, resourcing and other HR duties.

Statistical Programmer, 08/2015 - 08/2017

Developed quality control and documentation or statistical (SAS) programs in support of department projects. Planned and executed SAS programming activities for a single project.

Developed SAS programs for clinical trial activities to ensure clean and efficient code that was easily maintained. Contributed broad knowledge of clinical trial activities.

Theorem Clinical Research - King of Prussia, PA 1/2012 – 8/2015

Sr Statistical Programmer / Analyst

Partnered with professionals in the Oncology therapeutic area in phases 1 – 4. Led projects and provided programming support (CDISC knowledge of SDTM and ADaM specifications). Prepared documentation describing all datasets and variables.

Programmed customized data displays and shell displays for clinical research studies. Used Base SAS programs, SAS procedures, or standardized macros.

PRA International - Lenexa, KS 8/2007 – 12/2011

Analysis Programmer

Lea studies alongside Statistician in various therapeutic areas and phases, primarily phase 2 and 3 studies. An NDA submission was completed for a pain patch which was an ISS/ISE for 35 studies. Served as primary functional rep, providing input for analysis and reporting projects.

Helped plan documentation for the collection, handling, reviewing and cleaning of clinical data, in order to provide a high-quality clinical database. Reviewed Case report forms, Data handling guidelines, Data edit specifications and Data conversion specifications

Provided input into the statistical analysis plan and creation of table, figure, and listing specifications, collaborating with the lead biostatistician in order to provide high quality statistical analyses.

Mentored analysis programmers within a clinical trial project team.

Integrated database design, documentation and implementation and reviewed reports for consistency.

Education

Bachelors of Science (BS), Computer Information Systems Friends University, Wichita, KS

Contact this candidate