Olga Belotserkovsky

** ********* ****, *******, ** 18974

Home: 215-***-**** Cell: 267-***-**** e-mail: ad07t8@r.postjobfree.com Associate Director, Statistical Programming

Result-oriented professional with 23 years of hands on experience in SAS programming, data management, eCTD submissions, reports generation for clinical trials. 15+ years of managerial experience. Self-motivated with a proven track record in delivering high quality, timely output and developing innovative programming solutions.

Expertly leads programming projects involving multiple programmers.

Very efficient in managing multiple priorities and meeting deadlines in fast paced environment.

Excellent analytical and problem solving skills. PROFESSIONAL EXPERIENCE 05/2021 –present Bristol Myers Squibb, Lawrenceville, NJ Associate Director, Statistical Programming

Provide comprehensive programming leadership and support complex clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements and SOPs and work practices.

Drive the development and implementation of innovative strategies and technologies for clinical trial programming .

Independently develop, validate, troubleshoot, and maintain complex programs and utilities in accordance with predefined specifications and standards.

Lead the electronic submission preparation and review.

Review planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensure clarity and completeness of programming assignments.

Effectively recruit, manage, develop, evaluate, reward, motivate, and retain direct reports, resulting in an increasing level of capabilities within department.

06/2020 –05/2021 CSL Behring, King of Prussia, PA

Associate Director, Statistical Programming

Collaborated with other departments and vendors to provide necessary infrastructure and tools to support development of ADaM datasets, Tables, Figures, Listings and Analysis content.

Lead and oversaw vendor’s output production and validation of project deliverables.

Participated in new business development and bidding processes.

Programmed to support responses for regulatory requests, integrated summary of safety and efficacy, publications, planning of clinical studies.

Provided leadership and expertise in resolving complex problems in support of the company objectives and assigned projects.

Interacted with regulatory agencies and supporting in regulatory submissions.

Oversaw programming support activities.

Validated the accuracy, consistency and integrity of the deliverables.

Served as a primary contact between divisional areas and the vendors. 08/2016 –06/2020 Merck, Upper Gwynedd, PA

Associate Director, Statistical Programming

Managed a team of 15 full time programmers, 3 contractors and was overseeing the off-shore team, and the CRO work.

Was responsible for statistical programming activities for multiple late stage clinical development projects in Neuroscience and Vaccines therapeutic areas.

Was responsible for implementing departmental objectives and managing resource and operational challenges.

Negotiated and prioritized resource assignments with staff and stakeholders at a regional or global level ensuring that project plans are executed efficiently with timely and high-quality deliverables.

Ensured appropriate and consistent application of SOPs, standards, and quality and compliance measures.

Provided technical and scientific guidance to employees and colleagues. Stepped in as a programmer when the team members needed help with deliverables.

Actively participated in the process of creating SDSPs (Study Data Standardization Plans) for Vaccines.

Interacted with multiple cross functional areas to plan for the statistical analysis and reporting, and to identify areas for improvement and solve business challenges.

Major Accomplishments:

o Executed multiple FDA submissions for Vaccines and NS therapeutic areas. o Provided training and presentations to stakeholders and upper management on specifics of CBER requirements for Vaccines (SDSPs, Immunogenicity and Reactogenicity). 03/2014 –08/2016 Endo Pharmaceuticals (previously Auxilium Pharmaceuticals), Malvern, PA Senior Director, Programming

Managed a team of 4-6 SAS programmers and led data management group.

Provided programming support for various publications and SMQs, annual reports, DSUR and PBRER.

Provided detailed programming and quality control support for derived data sets, tables, listings, figures and ad hoc requests.

Supported development of general SAS programming tools to streamline the programming and quality control process for tables, listings and figures.

Created data acceptance, laboratory and immunogenicity reconciliation programs and medical coding approval programs to streamline data management processes.

Prepared derived datasets (SDTM and ADAM) and SAS programs for sBLA submissions to the FDA.

Assisted the regulatory department with the submissions to EU Ethic Committee and Health Canada.

Supported creation and quality review of data to be loaded into the clinical data warehouse.

Initiated, managed and coordinated activities of outside vendors for programming related tasks.

Took part in a Transition Team to transfer Auxilium's projects and processes to Endo Pharmaceuticals.

Led the migration process (datasets, programs, macros etc.) from local SAS server to the hosted SSOD (SAS on Demand) environment.

Major Accomplishments:

o Executed multiple FDA submissions (including ISS and ISE) that didn't require any subsequent follow up (no findings from the agency).

o Smooth completion (including the submission) of four simultaneous studies under very tight timelines. o Taking on responsibilities of the Executive Director of Programming role after she left the company. o Subject matter expert on CDISC standards.

2010 –2014 Auxilium Pharmaceuticals Inc., Malvern, PA Associate Director/Director, Programming

Managed a team of 6 SAS programmers.

Planned, managed and implemented the overall SAS programming process for clinical trials (Phase I – Phase IV).

Created and managed company specific standard programming tools (macros, templates) and developed standard programming processes for tables, listings and figures.

Provided primary and quality control programming support for derived data sets, tables, listings, figures and ad hoc requests for various studies.

Participated in SAS software validation.

2006 –2010 United BioSource Corporation (Biotechnology Solutions Group), Newtown, PA Manager, Clinical Programming

Managed a team of 5-7 Clinical Programmers in a variety of clinical trial studies.

Developed and reviewed SAS programs that create SDTM and derived datasets, tables, figures, listings and patient profiles.

Represented company in client meetings (bid defenses, project kick-off and result review meetings).

Implemented SOPs, programming work instructions, and process improvements.

Provided programming support for SMC, DMC, ASCO, IND submissions.

Represented programming team in project management meetings; provided time and resource estimates. o Trained and mentored Clinical Programmers to ensure departmental level of processes and quality was maintained at the highest standards.

o Reviewed Statistical Analysis Plan and provided feedback to statistical department. o Reviewed Case Report Forms and assisted in database design. o Contributed to company marketing and presentation materials. Major Accomplishments:

o Led a team to integrate a new table validation process into the standard programming procedure (a PhUSE paper on this process was published in October 2009). o Successful completion of robust ISS while meeting extremely tight timelines. o Managed and coordinated 'Mentor/Mentee' program in programming department. The program got a very positive feedback from both Mentors and their Mentees. 2004 - 2006 INC Research (Pharmaceutical Resource Corporation), Hatboro, PA Senior Statistical Programmer/Manager, Statistical Programming

Managed a group of up to 5 Statistical Programmers.

Consulted with statisticians and sponsors to determine functional specifications for each project.

Implemented SOPs and process improvements.

o Developed procedures and tracking tools to monitor project timelines. o Developed and reviewed SAS programs that create raw and derived datasets, tables, figures, listings and patient profiles.

o Trained and mentored Statistical Programmers.

Major Accomplishments:

o Created a SAS program that optimized and automated formatting process for all reports and combined them together saving a lot of time and efforts. o Conducted training program to introduce Programming group to Output Delivery System and worked on the transition from regular MS Word output to Rich Text Format. o Provided SAS GRAPH training for programmers and developed standard library for certain types of graphs.

o Developed Programming Standards/Training manual according to company’s SOPs. o Worked on the Data Management project as both project and data manager, assisted in data cleaning, produced queries, created edit checks in Oracle Clinical. 2000 –2004 Premier Research, Philadelphia, PA

SAS Programmer/ SAS Programmer II/Senior SAS Programmer

Maintained medical databases for ongoing pharmaceutical studies and made modifications as requested by the clients.

Provided listings and analysis tables of the data.

Developed SAS macros for production purposes across all studies.

Led programming projects involving multiple programmers.

Provided SAS programming and statistical analysis to support Clinical Data Management Department.

Validated SAS software.

Conducted various statistical tests for clinical trial phase I, II, III and IV studies.

Developed programming routines that combined multiple files into one document, and format output as Microsoft Word documents.

Assisted statisticians with annotation of table shells, Statistical Analysis Plan development, creation of derived

(analysis) dataset specifications.

Provided Base SAS, SAS ODS and SAS Viewer training for Clinical Data Management department.

Modified incoming data using SAS by reformatting, repositioning, creating, and labeling variables such that the data can be successfully analyzed.

Created edit checks in SAS to verify the accuracy of DataFax data sets. EDUCATION MS in Clinical Research and Organization (GPA 3.88), Drexel University, School of Medicine, 2009 BS in Applied Math and Computer Science, Kiev Polytechnic University, Kiev, Ukraine, 1999 PUBLICATIONS

"Validate it Again?! Get SAS to Do it!", in co-authorship with C.Matthews, G.Lewis, PhUSE (Pharmaceutical Users Software Exchange), October 2009.

Key Safety Assessments following Chimeric Antigen Receptor (CAR) T-cell Therapy in Early Development Oncology in co-authorship with Leanne Tenry, Tamara Martin, and Colin Zhou, Bristol Myers Squibb. Pharmasug 2023 TECHNICAL SKILLS SAS system: BASE, MACRO, STAT, SQL, GRAPH, ODS.

Computer Environments: Windows, MS DOS, Unix.

Database Software: MS Access, DataFax, Oracle Clinical, Inform. Programming languages: C, C++, SQL.

Spreadsheet and presentation software: MS Excel, Power Point.

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