positions: manager-statistical programming
location: pune, india
experience: 6 -15 years
essential skills/personality traits:
- sound knowledge of regulatory guidance documents such as ich-e3 and ich-e9
- good knowledge and understanding of cdisc sdtm and adam standards
- strong verbal and written communication skills
- service excellence oriented with analytical and problem-solving capabilities
- planning and prioritization of work with a concern of quality
- initiative and set the benchmarks for team members
operational responsibility:
- manage the programming activities for a global project following internal product guidelines
- will provide details solution requirements for development of analysis plans, mock shells, programming specifications, tables, listings and figures, data review and statistical analysis
- will provide detail approach and requirements (use cases, wireframes) on stdm modeling and mapping plans
- will provide detail approach and requirements (use cases, wireframes) on adam modeling and mapping plans
- will provide detail approach and requirements (use cases, wireframes) on tlg creation
- provide expert statistical input into and review of statistical deliverable and assist other team members in python/sas programming as and when required
- responsible for day-to-day work, process flows and constantly endeavoring to be able to lead by example
- ensure adherence to the company and client sops
- provide input to director, biostatistics and programming on resources, scheduling and timelines as required
- provide guidance and coordinate programming activities on the assigned activities so as to yield timely and high quality output
- coordinate and communicate effectively with primary contacts at client teams to ensure the satisfactory progress of project work and timely resolution of issues
- provide guidance and supervision to the direct reports for assigned project work; review in detail all work done by them before global teams review it