Applycup Hiring Solutions

Pune, Maharashtra

Positions: Manager-Statistical ProgrammingLocation: Pune, IndiaExperience: 6 -15 yearsESSENTIAL 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 membersOPERATIONAL 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