Director/Associate Director - Clinical SAS Programming

Job Title::- Director/Associate Director-Clinical SAS Programmer-Hyderabad

Location::- Hyderabad

Please fine the JD below

The Associate Director Statistical Programming is responsible for all statistical programming aspects of one or more drug development projects and/or acts as technical expert on a project with high business impact. The position is a key leader with biostatistics in ensuring that pharmaceutical drug-development plans in Oncology are executed efficiently with timely and high quality deliverables. It is a leader role with strong understanding of drug development process, experience in regulatory activities and key statistical reporting aspects with a track record of operational, organizational and/or technical leadership.

Major Activities

1.Lead statistical programming activities as Program Programmer for a full development project or groups of projects in Clinical Pharmacology (CP)/Translational Clinical Oncology (TCO)/Global Medical Affairs (GMA), develop statistical programming strategy and scientific documentation for the project(s) together with the Biostatistician(s). If assigned to cross-project aligned group (e.g. Standards), manage large/complex global project that has high business impact, or manage a focus area.

2.Manager of all internal statistical programmers assigned to the project(s). Provides performance management, supervision and advice to these programmers on functional expertise and processes, responsible for their professional development/training. Build highly efficient team.

3.Co-ordinate activities of all programmers assigned to the project(s) internally and externally (FSP, CRO), assess resources, negotiate their priority assignments on the project(s) and act as project manager for statistical programming deliverables.

4.Provides authoritative technical and professional recommendations as representative of the statistical programming function at project level.

5.Build and maintain effective working relationship with cross-functional teams incl. Biostatistics and Data Management counterparts, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan) as member of the International Clinical Team (or equivalent) and with the Unit Head in Statistical Programming.

6.Comply with company, department and CDISC standards and processes, ensuring statistical programming innovations and foster statistical programming solutions, ensure their efficient implementations and knowledge sharing within and outside the project(s).

7.Accountable for timely and quality development and validation of all statistical programming components on assigned project(s). Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results.

8.If assigned to cross-project aligned group (e.g. Standards), be responsible for the end-to-end development of large/complex global project with high business impact and/or collaboration with GenMeds/NIBR on standardization efforts or technical system enhancements. Manage a focus area including global coordinating activities for people involved in the project(s).

9.Represent Statistical Programming at audits and in Health Authority (HA) meetings for assigned project(s), or on technical programming aspects in external conferences or groups (e.g. CDISC).

10.Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and trainings.

11.Act as subject matter expert (SME) or lead process improvement/non-clinical project initiatives with a focus on programming and analysis reporting procedures.

12.Recruit talent, coach and develop statistical programmers

Qualifications Required :

Any Graduate or Post Graduate

Experience/Professional requirement:

1.Expert SAS experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs

2.Expert experience in contributing to statistical analysis plans and/or constructing technical programming specifications

3.Advanced knowledge of CDISC data structures as well as a solid understanding of the development and use of standard programs

4.Advanced understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and clinical study practices, procedures and methodologies.

5.Proven communications and negotiation skills, ability to work well with others globally and influence.

6.If assigned to cross-project aligned group, proven ability to effectively act as statisticial programming representative on standardization efforts, software/technical enhancements and/or proven ability to participate in external Pharma groups on programming related matters (e.g. CDISC)

7. 2+ years experience as Senior Principal Programmer for several studies, a large indication or project-level activities, preferably in Oncology, including coordination of large team of internal or external programmers

8.Ideally 8+ years industry experience in programming/ statistical role

Nisha Sharma
9810982047