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Team Lead - Statistical Programming

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

The Team Lead, Statistical Programming, is overall responsible for statistical programming for assigned clinical trials in Scientific Services. The team lead is also responsible for leading other statistical programming members locally on a project(s) while collaborating with the Group Leader, in order to 1. Lead Statistical Programming team deliverables for assigned projects(s) across multiple disease areas and all phases of drug development through to post-marketing and provides technical leadership. 2. Provide organizational leadership by managing assigned group of 5-10 statistical programming Coordinates and leads the work of Statistical Programming resources for assigned group. Support Group Leader to establish high performing, industry recognized Statistical Programming organization. Collaborates with the Group Leader to support and ensure the flexible coordination of activities to deliver at the trial level for assigned trials and projects(s). Collaborates with the Lead Statistician/ Functional Lead to support and ensure optimal resource to support assigned activities. Ensures high quality, timely communication and trial information (resources, status of assigned activities, issues) flow to Group Leader. Serves as the Lead Statistical Programmer for trials providing timely, constructive, technical input into trial and project teams. Ensure timely, efficient high quality function specific deliverables for projects and trials. Responsible for professional development/training, performance management and mentoring of associates, liaising with the Group Leader Provide input, review, and maintenance to working practices and standards, as needed. Ensures high quality, timely communication and project information (resources, status of assigned activities, issues) flow to Group Leader and respective local site leadership. Recruits and retains talents locally; coaches and develops associates to enable them to provide the highest levels of scientific and technical capabilities. Establishes a group founded on innovation, high performance and trust. Track and report status and progress of activities for allocated trials and be proactive to ensure smooth and successful timely deliverables from team. Takes an active contributing role in PLSS initiatives and forums.Achieve assigned project goals as set each year by Group Leader. All assigned project deliverables conducted locally meet targets for quality, time and cost in adherence with business standard operating procedures. Achieve Talent Pipeline objectives (coaching people for high performance and high potential, building a diverse talent pool, feeding the Novartis talent pipeline, attracting and retaining the best people). No critical findings as result of routine audits or health authority inspections Adhere to Novartis standards, in particular quality, ethical, health, safety and environment (HSE), and information security (ISEC) standards. Meeting metrics on performance management, TMS updates and training complianceMinimum requirementsBA/BSc/MSc/PhD (or equivalent) in mathematics, statistics, computer science/programming or health sciences/related field. - Fluent English (oral and written). Good skills in site (local) language desired (oral) - 8+ years industry/ relevant experience - Expert knowledge of / experience with SAS and other relevant programming software. - Proven track record in successfully leading Statistical Programming teams in matrix environment - Ability to operate effectively in a global environment - Attention to detail and quality focused - Established track record of active contributions within the line function as well as ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills. - Working knowledge of database design/structures and basic statistics. - Working experience of leading pooling analysis datasets across multiple clinical studies for clinical development program (or equivalent) - Good understanding of global / project practices, procedures, methodologies. - Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
Degree: M.Sc. (Science) | Ph.D. (Doctorate)

Additional Degree: BA (Arts) | B.Sc. (Science)

Experience: 8-13


Clinical Research | Data Management/ Statistics
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