Manikandan Bakthavatsalam
Director, Statistical Programming
Hopkinton
Summary
With over 16 years of SAS programming expertise, I have successfully led project management efforts in various therapeutic areas such as Oncology, Nervous system, Hematology, Respiratory, Endocrine/Metabolic, Digestive System, and Musculoskeletal. My strong background in CDISC SDTM/ADaM standards and regulatory submissions has enabled me to provide technical consulting to internal and external clients. As a Programming Manager and Oversight for large global programs, I have contributed significantly to department initiatives and process improvements. In my role as Global Resourcing Leader, I manage resourcing for 40+ programmers and projects while ensuring compliance with regulatory guidelines and industry standards across multiple clinical trial phases.
Overview
20
20
years of professional experience
6
6
years of post-secondary education
4
4
Certifications
Work History
Director, Statistical Programming
Sarepta Therapeutics
03.2023 - Current
- Develops/maintains standards and processes for Statistical Programming function; contribute to development of cross-functional standards and processes.
- Leads non-project initiatives across statistical programming.
- Successfully engages cross functionally to progress tasks with proven influencing skills.
- Provides strategic and technical expertise in statistical programming for clinical development programs and regulatory submissions.
- Forecasts and manages Statistical Programming resources to meet current and future business needs; establish and maintain vendor partnerships.
- Ensures proper role and contribution by Statistical Programming in various stages of clinical studies, including review of case report forms, review of statistical analysis plans, development of shells for tables, figures and listings, programming support of data cleaning, ad hoc and exploratory analyses, interim and final analyses, publications, etc.
- Leads statistical programming efforts for NDA, MAA and other regulatory submissions, including SDTM and ADaM datasets and associated define files, tables/figures/listings for integrated summaries (ISS and ISE), etc.
- Leads statistical programming efforts to support innovative statistical approaches and meta-analyses.
- Represents Sarepta as Subject Matter Expert on clinical data submission in meetings with FDA and other regulatory agencies; and provides leadership in addressing clinical data submission questions/comments from FDA and other regulatory agencies.
- Accountable for recruiting, resource planning, talent development and management in Statistical Programming Group to meet current and future business needs.
- Responsible for coaching, mentoring, and performance management of direct reports.
- Typically directs the statistical programming activities of one or more clinical development programs or functional areas.
- Obtains alignment with Biostatistics or Biometrics team lead as well as Stat Programming management on complex tasks/activities.
- Uses advanced coding techniques and company policies and procedures to complete complex tasks/activities or solve complex problems in creative and effective ways.
- May oversee the activities of junior team members; may have direct reports.
- Demonstrated success in technical proficiency, scientific creativity, and collaboration with other functional groups.
- Works on highly complex tasks/activities/problems in which analysis of situations or data requires an in-depth evaluation of various factors including intangible variables.
- Makes significant impact on study or program level activities.
Associate Director, Statistical Programming
Sarepta Therapeutics
09.2019 - 03.2023
- Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).
- Familiar with statistical analysis methods and clinical data management concepts.
- Produce and deliver CDISC and regulatory compliant SDTM, and ADaM standard datasets.
- Develop and execute statistical analysis and reporting deliverables (tables, figures and listings (TFLs)) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
- Provide support for Biometrics systems/tool and coordinate with QA, IT and other functional areas for user requirements, validation plan, system design specification, and IQ/OQ/PQ.
- Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets, fit-for-purpose analysis datasets, and TFLs.
- Review or author SDTM and ADaM datasets specifications for datasets programming.
- Provide programming support for building integrated summary of safety/efficacy datasets and analysis.
- Provide programming support for ad-hoc analysis.
- Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).
- Manage project timelines and schedules of specific phases of projects with internal personnel and external vendors.
- Provide oversight of statistical programming activities of vendors.
- Participate in the development and review of Statistical Programming SOPs.
- Train or mentor junior statistical programming staff.
Manager
PPD Inc
04.2016 - 08.2019
- Manage multiple project teams to ensure the team understands the client standards/needs, produce high quality deliverables on time and within the budget.
- Provide project oversight of studies or sponsor programs and leadership for strategic client relationships and portfolios.
- Act as a key contact for client interactions and bid defenses and ensures effective delivery across all project requirements including communicating priorities and proactively identifying and resolving any risks.
- Acts as Global Resourcing Leader (GRL) for Austin site to manage the resourcing of 40+ programmers, Team assignment for New projects, resolve resourcing risks across projects by working with GRLs across various regions (i.e.) EMEA, APAC, NA and provide innovative ideas and resourcing strategies for the future work.
- Perform supervisory responsibilities for the staff, setting their annual goals, conducting performance reviews and meet regularly for coaching towards their career development.
- Provide strategies to senior management on ways to improve department processes and lead department initiatives on various areas.
- Represent programming group on client and regulatory audits, client partnership meetings, face to face project kick off and strategies meetings.
- Provide technical guidance to internal teams and client on various regulatory standards including SDTM, ADaM and eCRT.
- Experience in chairing department meetings on various topics, training new hires and staff on SOPs, tools, various technical and non-technical areas.
- Represented company and department on multiple conferences to provide details on our services.
- Participate in screening and interviewing to hire right people for the organization.
- Provide SDTM review / mapping, eCRT development/review, ADaM specification, programming support, tool and macro development for complex needs.
- Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
Programming Team Leader
PPD Inc
10.2013 - 03.2016
- Responsibilities in previous positions: Served as a Project Lead, Lead Programmer and Lead Quality Validator in several studies with critical timelines and consistently met critical deliverable targets.
- Supported Data Management teams with data cleaning using data Listings and worked closely with Biostatistics teams with various tasks including programming SDTM, ADaM, TLF (Table, Listing, Figures) generation, Export and Import tasks using SAS and SQL.
- Extensively worked with complex and huge datasets, generated reports in various formats such as PDF, RTF, HTML, CSV and list files.
- Monitored staff assignments, evaluates and shifts priorities and assignments to meet timelines and deliver high quality work.
- Provides feedback to management when timeline or resourcing constraints develop.
- Provided mentoring, leadership and supervision to staff.
Senior Programmer Analyst
PPD Inc
04.2011 - 10.2013
Programmer Analyst
PPD Inc
10.2009 - 03.2011
SAS programmer
Meridian Information Systems, LLC
08.2009 - 09.2009
- Develop SAS Programs to extract clinical trial data from database, export mapped data, and generation of Statistical tables, listings and graphs.
Programmer Analyst
Kelly Services, Inc.
12.2008 - 07.2009
- Worked as a Contract Programmer/Analyst at PPD, Inc. through Kelly Services, Inc. and continued to work with responsibilities of Programmer Analyst.
Programmer Analyst
PPD Inc
10.2008 - 12.2008
Associate Programmer Analyst
PPD Inc
06.2007 - 10.2008
Graduate Instructional Assistant
Texas State University
10.2005 - 06.2007
- Assistant Instructor in Computer Technology Lab, Hardware and Software installation.
- C, C++ programming, Web Designing and Microsoft Office.
- Computer Lab setup - Hardware and Software installation.
Education
Master of Science - Computer Science
Texas State University
San Marcos, TX 05.2005 - 06.2007
Bachelor of Engineering - Computer Science and Engineering
Anna University
Chennai, India 05.2001 - 05.2005
Skills
Project Management
Certification
SAS Base Programming for SAS9.
Awards
- One Sarepta Team Award, Sarepta, 2022-08-01
- Cultural Value Award, Sarepta, 2020-01-01
- CEO Performance Excellence Award, PPD, 2012-11-01
- CEO Performance Excellence Award, PPD, 2015-11-01
- Peak Performance Team Award, PPD, 2011-01-01
- Graduate Academic Excellence for Year 2007 and 2008, Department of Computer Science, Texas State University, 2008-01-01
Timeline
Director, Statistical Programming
Sarepta Therapeutics
03.2023 - Current
Associate Director, Statistical Programming
Sarepta Therapeutics
09.2019 - 03.2023
Manager
PPD Inc
04.2016 - 08.2019
Programming Team Leader
PPD Inc
10.2013 - 03.2016
Senior Programmer Analyst
PPD Inc
04.2011 - 10.2013
Programmer Analyst
PPD Inc
10.2009 - 03.2011
SAS programmer
Meridian Information Systems, LLC
08.2009 - 09.2009
Programmer Analyst
Kelly Services, Inc.
12.2008 - 07.2009
Programmer Analyst
PPD Inc
10.2008 - 12.2008
Associate Programmer Analyst
PPD Inc
06.2007 - 10.2008
Graduate Instructional Assistant
Texas State University
10.2005 - 06.2007
Master of Science - Computer Science
Texas State University
05.2005 - 06.2007
Bachelor of Engineering - Computer Science and Engineering
Anna University
05.2001 - 05.2005
Similar Profiles
Juston WeemsJuston Weems
Director, Assay Strategy Execution at Sarepta TherapeuticsDirector, Assay Strategy Execution at Sarepta Therapeutics
Sarah KwasSarah Kwas
Associate Director, Field Training at Sarepta TherapeuticsAssociate Director, Field Training at Sarepta Therapeutics
Mike LoboscoMike Lobosco
Executive Director/ Sr Director, Commercial and Medical Affairs Field Operations, Training & Field Effectiveness at Sarepta TherapeuticsExecutive Director/ Sr Director, Commercial and Medical Affairs Field Operations, Training & Field Effectiveness at Sarepta Therapeutics
SAMANTHA BERENSONSAMANTHA BERENSON
Undergraduate Research Assistant at Michigan State UniversityUndergraduate Research Assistant at Michigan State University
Michael MannMichael Mann
Volunteer at Project Just BecauseVolunteer at Project Just Because