More than 19 years of experience in statistical programming at several CROs across all phases of clinical researchHas worked on local and global teams and at Canadian, American and European companies in both traditional and FSP arrangementsVery strong SAS skills for building datasets, outputting TLFs and performing or validating statistical analysesSpecialist in creating and double programming ADaM datasets, producing ADaM specifications, advising teams on CDISC compliance and working with SDTM dataDetail and quality orientedAchieves and maintains a high level of accuracy on all productsSufficient statistical expertise to question specs and programmed resultsProactively self-trains, enjoys mentoring intermediate/senior programmers, participates in initiative/standards/wellness groupsAble to write clear, documented and defensive programs which may be easily reused or delivered to sponsorStrong communication and teamwork skills and an excellent work ethicTherapeutic area experiences:- autoimmune/inflammation- infectious disease- metabolic- cardiovascular- oncology- biomarkers- dermatology- genitourinary- behavioural- central nervous system- human abuse potential (HAP)- rare diseaseSpecialties:- Statistical programming, validation and documentation (PC/UNIX/Linux SAS, SAS Grid/EG/Studio/LSAF, P21, Define-XML, R)- ADaM and TLF production and validation/double programming, defensive programming, working with SDTM data, recent ADaM spec experience under members of the global ADaM IG team- SAS macros, server SAS, batch programs, SAS jobs- CDISC experience, ICH compliance, FSPs and client-specific SOPs- Data pooling, oncology, recent rare disease work- Statistical analysis and SAP/SPP development, comfortable collaborating with statisticians- DMC/DSMB reporting- IVRS/IWRS data management/randomization audits- CRF design- VBA programming/database design- C, Java/object-oriented programming, Tcl/Tk, Perl, SQL, Pascal, Basic, HTML- Familiar with practical methods of statistics, well-developed mathematical skillsLatest project at Fortrea:I was faced with a situation where tabulating ADCM data failed because CMDECOD was getting truncated. Tracking it backwards, I realized that this needed to be solved in CM/SUPPCM. Long story short, I was also able to implement some macros provided by the client at the table level (in order to indent/paginate really long text). I will give a training about this to the entire FSP, adding value on both sides. Sometimes we are all so billable that we have no time to learn how to improve!