We specialize in Business Intelligence, Application Development , Clinical Data Analysis and Professional Services.

Careers & Job Postings

Clinical Data Manager 

Responsibilities Serves as primary Data Manager contact for assigned studies, including representation on project teams and working with
CRO’s performing data management tasks for assigned study.

• Coordinates, leads and performs clinical data management activities for assigned studies in accordance with
Client's SOP’s and policies and practices including, not limited to:
• Monitors data clean-up process performed by CRO’s from study start-up through data archiving.
• Provides data for analysis
• Coordinates activities including: medical coding; data validation checks and database snapshot
• Prepares and distributes project status reports to project team and management.
• Functions as DM team leader responsible for ensuring databases are validated and ready for transfer and/or
analyses in accordance with Client SOP’s.
• Creates and maintains project documentation, including, but not limited to, Data Management Manual, CRF
Completion Guidelines and validation specifications, and work instructions for assigned projects. Designs and
modifies CRF.
• Responsible for the initiation and approval of the building, testing and validation of clinical databases,
subsequent changes in clinical databases and data validation activities.
• Contributes to upkeep Client DM outsourcing strategies and long-term relationships with outsourcing
partners with objective of ensuring data quality and efficiencies through data and process standardization.
• Works with study team and coordinates all data management functions. Manages coordination of CRO data
manager and project team to ensure that tasks are performed according to policies and procedures.
Adheres to procedures surrounding retention of data, records, and information for clinical studies

Qualifications:

Bachelor degree in Pharmaceutical Science or a related field, along with 3 or more years of clinical data
management experience in biotechnology, pharmaceutical or health related industry. Previous oncology and/or
ophthalmology experience a plus.
Self directed and comfortable working in teams with the ability to work and operate independently within a tight
deadline environment. High degree of creativity, latitude and attention to detail required.
• Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines. Strong analytical and project
mgmt skills. Strong written and oral communication skills required.
Proficient with appropriate EDC applications and Microsoft Office applications. Software proficiency with CDMS
required. Experience with JMP and SAS a plus.
 

 Contact : Contact@mminfotechinc.com

Senior Statistical Programmer 

A senior statistical programmer provides timely support to the study team on all programming matters according to
the project strategies. As an integral part of a study, the incumbent provides project leadership and programming
support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis
Plan and programming specifications using internal standards and guidelines. The incumbent assists in providing
guidance in implementing and executing the programming and project standards. The evaluation and development
of study requirements and validation plan are also in the scope of this position. Works independently to design and
test program logic, coding programs, program documentation and preparation of programs. Lead all aspects of
projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets
statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code,
logs, and output in a regulated environment.

•Support and/or lead programmer for programming and QC of analysis datasets, TFL's or standard tools
following Regeneron standard data models or user requirements. Coordination of activities and communicate
shifting timelines and achievements.
• Integration of data across studies in support of CSS/CSE. Create, manage and maintain the programming
specifications for the analysis datasets utilizing Regeneron tools and methodologies.

•Support creation and validation of esubmission requirements (i.e. annotated CRF, data export files, define
documents).
• Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical
trials up to regulatory approval, product launch and annual reports,. If applicable, develop and provide
department training for applications and standard tools developed by the department functions group.
• Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more
complex data presentations.
• Participate in department working groups; provide input in development of tools and improvement of processes.

Qualifications:

• Adheres all direct reports about the procedures surrounding retention of data, records, and information for
employees in their group.
• Also acceptable - MS. in Statistics, Computer Science, Mathematics, Engineering, Life Science or related
subject area with 3+ years of programming experience preferably in processing clinical trial data in the
biotechnology, pharmaceutical or health related industry. SAS Certification desirable.
• Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices,
methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
• Strong SAS programming skills, preferably in a clinical data environment.
• Strong understanding of relational database structure.
• Understanding of reporting systems utilizing multiple data delivery applications.
• Experience with implementing standardization methodology.
• Demonstrated teamwork and interpersonal skills. Ability to problem solve. Strong verbal and written
communication skills in a global environment.
• Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis)
and ability to provide programming support needs for BLA and other regulatory submissions.
• Some experience in project management with supervision. Ability to organize and manage multiple assignments
with meaningful timelines for a limited number of personnel.
• Problem solving and innovative skills that demonstrate initiative and motivation.
• Ability to support multiple assignments with challenging timelines.
• Familiarity with the development and execution of user requirements, validation plans, operational and
performance protocols.
• Knowledge in creation of current CDISC data structures.
• SAS, (Base, Stat, Macro, graph).
• May report to a Manager or above

 

 Contact : Contact@mminfotechinc.com

We partner with enterprise organizations
to provide onsite and remote resources for short, medium and long-term projects.

Senior Project Manager
Responsibilities Coordinate with internal team and third parties/vendors for the project tasks, activities Ensure project on-time schedule, within scope and budget Ensure resource availability and allocation Develop a detailed project plan to monitor and track progress Manage project scope, project schedule and project costs Measure project performance using appropriate tools and techniques Report and escalate project risks/issues to management as needed Manage the relationship with the client and all stakeholders Perform risk management to minimize project risks Perform risk mitigation analysis and provide workaround solutions Create and maintain comprehensive project documentation Track project performance, status.

Qualifications
Bachelor’s Degree in appropriate field of study Equivalent work experience of 12-15+yrs Proven working experience in project management Excellent client-facing and internal communication skills Excellent written and verbal communication skills Solid organizational skills including attention to detail and multitasking skills Strong working knowledge of Microsoft Office, G-Suite Project Management Professional (PMP) / PRINCE II certification is plus Finance business process knowledge and experience in Procure to Pay and Accounts Receivables Atleast 4+ years of experience working in SaaS based products and software Contact : Contact@mminfotechinc.com