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Job Title: Sr. Statistical Programming Analyst
Duration: 12 months
Location : Upper Gwynedd PA
A – Operations
Major Responsibilities
Leads programming activities required for analysis and reporting of clinical
trials and regulatory submissions for large and critical programs.
Accountable for meeting project timelines, major project milestones and
overall project quality for assigned compounds/indications. Develops and
manages project plans for programming activities. Leads global team on
deliverables for a clinical trial or submission. Serves as lead programming
representative on study teams and submission teams. Works closely with the
statistician and cross-functional teams to define requirements for
statistical analysis and regulatory submissions. Provides resource estimates
, establishes timelines, leads quality control processes and provides
project leadership for one or more clinical programs. Leads strategic
technical or process improvement initiatives. Provides project leadership
for development of deliverables for a regulatory submission, including
integrated summaries of safety and efficacy, data files that adhere to
regulatory standards, and statistical review aids.
• Able to lead programming teams in a global environment
• Build skills needed to execute current responsibilities: Technical
– SAS skills; and Team Lead – soft skills, communication, leadership
behaviors, etc.
• Provide knowledge transfer as and when required in the process
• Build skills of others
• Encourage and imbibe culture of creativity and innovation
• Present topics that enhance team’s knowledge
B – Teamwork
• Work with all other onshore and offshore therapeutic area and shared
service roles to promote consistent operations, efficient use of resources
and sharing knowledge/best practices. Support management of BARDS in
achieving common goals.
• Promote teamwork within assigned therapeutic areas. Find common
ground, communicate and proactively share information.
• Interact with Clinical//BARDS teams to understand and meet their
needs.
• Optimize the contribution of group members through coaching,
counseling and mentoring activities.
• Act as internal advisor to peers and Managers related to performance
, best practices and overall service delivery.
• Mentor new Project Managers
C – Process & Technology • Identify efficiencies in process/
technology, influence direction of group or project by leveraging own
specialist knowledge. • Understand and work to the current divisional
/ departmental SOPs and SPIs, ensuring deviations are documented
appropriately. Propose new and revise current procedures as appropriate.
8226; Lead and serve on teams to optimize processes and use of BARDS related
technology to build a more efficient organization. Encourage practical
applications of new ideas. • In-depth expertise in SAS programming and
experience with efficacy/safety reporting. • Broad knowledge of
clinical trials processes, clinical data, data structures and corresponding
tools used to manage, extract, analyze and report data. • Demonstrated
experience in complex data reporting in a statistical environment."
Bachelors Degree with 6 years relevant experience involving statistical
programming in the clinical trials environment or Masters Degree with 4
years relevant experience involving statistical programming in the clinical
trials environment
- Minimum 5 years' Base SAS programming experience and basic statistical
procedures required
- Minimum 2 year experience implementation of CDISC industry standard, SDTM,
ADAM
Professional Skill Requirements
- Minimum 3 years' leadership experience in clinical trials programming
Preferred Qualifications:
- Advanced SAS Macro Language
- SAS/GRAPH
- SAS/SQL
- SAS/STAT
Professional Skill Requirements
- Excellent leadership, communication (written and oral) and interpersonal
skills
- Proven success in contributing to a team-oriented environment
- Proven ability to work creatively and analytically in a problem-solving
environment
- Desire to work in an information systems environment
If you are interested, please respond at your earliest convenience, along
with an updated resume. It would be very helpful if you could provide the
following information to aid in the process;
1. Your current location (city & state):
2. Contact number:
3 Expected rate / compensation:
4. Date of availability:
5. Work Authorization Status:
Duration: 12 months
Location : Upper Gwynedd PA
A – Operations
Major Responsibilities
Leads programming activities required for analysis and reporting of clinical
trials and regulatory submissions for large and critical programs.
Accountable for meeting project timelines, major project milestones and
overall project quality for assigned compounds/indications. Develops and
manages project plans for programming activities. Leads global team on
deliverables for a clinical trial or submission. Serves as lead programming
representative on study teams and submission teams. Works closely with the
statistician and cross-functional teams to define requirements for
statistical analysis and regulatory submissions. Provides resource estimates
, establishes timelines, leads quality control processes and provides
project leadership for one or more clinical programs. Leads strategic
technical or process improvement initiatives. Provides project leadership
for development of deliverables for a regulatory submission, including
integrated summaries of safety and efficacy, data files that adhere to
regulatory standards, and statistical review aids.
• Able to lead programming teams in a global environment
• Build skills needed to execute current responsibilities: Technical
– SAS skills; and Team Lead – soft skills, communication, leadership
behaviors, etc.
• Provide knowledge transfer as and when required in the process
• Build skills of others
• Encourage and imbibe culture of creativity and innovation
• Present topics that enhance team’s knowledge
B – Teamwork
• Work with all other onshore and offshore therapeutic area and shared
service roles to promote consistent operations, efficient use of resources
and sharing knowledge/best practices. Support management of BARDS in
achieving common goals.
• Promote teamwork within assigned therapeutic areas. Find common
ground, communicate and proactively share information.
• Interact with Clinical//BARDS teams to understand and meet their
needs.
• Optimize the contribution of group members through coaching,
counseling and mentoring activities.
• Act as internal advisor to peers and Managers related to performance
, best practices and overall service delivery.
• Mentor new Project Managers
C – Process & Technology • Identify efficiencies in process/
technology, influence direction of group or project by leveraging own
specialist knowledge. • Understand and work to the current divisional
/ departmental SOPs and SPIs, ensuring deviations are documented
appropriately. Propose new and revise current procedures as appropriate.
8226; Lead and serve on teams to optimize processes and use of BARDS related
technology to build a more efficient organization. Encourage practical
applications of new ideas. • In-depth expertise in SAS programming and
experience with efficacy/safety reporting. • Broad knowledge of
clinical trials processes, clinical data, data structures and corresponding
tools used to manage, extract, analyze and report data. • Demonstrated
experience in complex data reporting in a statistical environment."
Bachelors Degree with 6 years relevant experience involving statistical
programming in the clinical trials environment or Masters Degree with 4
years relevant experience involving statistical programming in the clinical
trials environment
- Minimum 5 years' Base SAS programming experience and basic statistical
procedures required
- Minimum 2 year experience implementation of CDISC industry standard, SDTM,
ADAM
Professional Skill Requirements
- Minimum 3 years' leadership experience in clinical trials programming
Preferred Qualifications:
- Advanced SAS Macro Language
- SAS/GRAPH
- SAS/SQL
- SAS/STAT
Professional Skill Requirements
- Excellent leadership, communication (written and oral) and interpersonal
skills
- Proven success in contributing to a team-oriented environment
- Proven ability to work creatively and analytically in a problem-solving
environment
- Desire to work in an information systems environment
If you are interested, please respond at your earliest convenience, along
with an updated resume. It would be very helpful if you could provide the
following information to aid in the process;
1. Your current location (city & state):
2. Contact number:
3 Expected rate / compensation:
4. Date of availability:
5. Work Authorization Status:
