Require Head – Biostatistician in Panacea Biotec

Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
We offer stimulating work environment & a career that spells growth. In tune with our plans, we require young, aggressive, dynamic, high performing and result oriented professional.

Post: Head – Biostatistician

Job Description

Establish and track overall Biostatistician performance measures. Provide leadership, technical expertise and project guidance to Data Management team.
Responsible for customer contact, functional, administrative and financial oversight of data management tasks in clinical trials (Phase I – IV) and non-interventional studies
Manage a team of data experts, to develop and manage development of the Biostatistician project deliverables
Manage projects to ensure completion of assignments within established timelines
Lead the development and implementation of processes, procedures and training for the data management function as directed
Interact with CROs, clinical team & Biostatistics to ensure complete understanding of Biostatistician responsibilities and expectations
Report progress against schedules to management as appropriate
Supervise Biostatistician integration activities among all PBL data management sites in region
Review subordinates’ performance and lead the team to achieve higher standard
Participates in the review of Clinical research documents (eg. Case Report Forms, Reports and Statistical analysis).
Reviews and approves all Biostatistician documents e.g. CAPA, DMP, DHR, DVG, Edit Specification, QC/UAT Reports, SAE Reconcilliation document, etc.
Lead RDC / EDC database (DB) implementation process
Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
Perform training of RDC trials and reviews user guides
Ensures process improvement to achieve overall Data quality delivered by the team is as per the regulatory standards and with complete adherance to SOPs. Direct team members in daily activities and co-ordinate, validate & review data management activities of the team.
Supervise in defining and creation of data listings, summary table validation, data specifications for statistical review and/or data management audit
Responsible for ensuing that the responses to CAPA (Corrective And Preventive Action ) is being provided by the Biostatistician team on time and satisfactorily implemented.
Collaborate with IT and implementation team(s) to address Clinical application requests and/or changes to Clinical database systems
Ensures data system compliance by following the established guidelines of national and international regulatory authorities
Participate in conferences and/or workshops, in order to enhance knowledge & skills of the team, keeping pace with current industry standards and practices.
Plan, organize, and assign projects to Biostatistician team to assure compliance with contractual/ regulatory requirements of projects and to ensure optimum efficiency
Solve operational problems related with database (front end) and Biostatistician processes.
Participate in the interview processes for vacancies of Biostatistician personnel and provide the senior management with information to make a decision about whether a match exists between the position and the candidate
Vendor Selection for clinical data management activities.
Contribute to database lock activities like giving approval for soft lock.
Mentor project team members
To develop KRAs of Biostatistician team and ensure that timelines and objectives are met as per the same.
Identifying gaps in processes and advise implementation/ upgradation of new software(s), as applicable.
Optimizing the use of software licenses.

Additional Information:
Experience: 8 yrs and above and should be experienced Biostatistician professionals
Age: 30-40 years
Location: Corporate Office – New Delhi
Education: Masters in Clinical Research or equivalent
Industry Type: Pharmaceutical
Functional Area: CR
Last Date: 16^th Feb., 2014