Associate Director Statistical Programming
Novartis
3 months ago
On-site
Cambridge, MA
$145,600 - $270,400 USD yearly
Clinical Research and Development
Key Responsibilities:
- Lead statistical programming activities for multiple clinical trials within a program or an indication/disease area, or development program.
- Ensure timely, quality development and validation of all statistical programming components for assigned programs; maintain audit readiness and ensure accuracy and reliability of statistical analysis results.
- Coordinate internal/external programmers; make statistical programming decisions and propose strategies at program/indication/disease level; develop scientific documentation with Biostatisticians.
- Allocate resources within a program and ensure resource sharing between programs to meet AQS and organizational goals.
- May serve as an operational and/or functional manager of associates, providing supervision and guidance.
- Recruit, mentor, and develop statistical programmers.
- Maintain cross-functional relationships within clinical trial/program; communicate deliverable status and critical programming aspects (timelines, scope, resource plan).
- Maintain advanced knowledge of programming software (e.g., SAS/R) and industry requirements (e.g., CDISC, eCTD, Define.xml); attend functional meetings and training.
- Represent statistical programming at indication/program level in audits/inspections and Health Authority meetings; contribute to external conferences/consortiums.
- Provide expert technical recommendations and thought leadership for the Statistical Programming function and non-clinical initiatives.
Essential Requirements:
- BS/MS in life science, computer science, statistics, mathematics, or equivalent; 6+ years in a programming/statistical role.
- 3+ years leadership/line management experience (including matrix management for people managers); ability to manage multiple trials and meet deadlines.
- In-depth understanding of clinical trial methodology, regulatory requirements, and Good Clinical Practice (GCP).
- Expert in SAS or R; develop and validate deliverables in a Statistical Programming environment; create advanced MACROs and/or functions.
- Significant experience contributing to statistical analysis plans and developing technical programming specifications.
- Advanced knowledge of industry standards, including CDISC; understanding of development and use of standard programs.
- 2+ years as a Lead/Program/Project Programmer for programs/indications, coordinating large internal/external teams.
- Excellent interpersonal skills; ability to influence and communicate in a global environment with internal/external stakeholders.
Desired Requirements:
- 10+ years experience in a programming or statistical role (equivalent).
Benefits (as stated):
- Performance-based cash incentive; eligibility for annual equity awards depending on level.
- US-based eligible employees: comprehensive benefits package (health, life, disability), 401(k) with company contribution and match, and other benefits; time off (vacation, personal days, holidays, and other leaves).
Application instructions:
- Not specified in the provided text.
- Lead statistical programming activities for multiple clinical trials within a program or an indication/disease area, or development program.
- Ensure timely, quality development and validation of all statistical programming components for assigned programs; maintain audit readiness and ensure accuracy and reliability of statistical analysis results.
- Coordinate internal/external programmers; make statistical programming decisions and propose strategies at program/indication/disease level; develop scientific documentation with Biostatisticians.
- Allocate resources within a program and ensure resource sharing between programs to meet AQS and organizational goals.
- May serve as an operational and/or functional manager of associates, providing supervision and guidance.
- Recruit, mentor, and develop statistical programmers.
- Maintain cross-functional relationships within clinical trial/program; communicate deliverable status and critical programming aspects (timelines, scope, resource plan).
- Maintain advanced knowledge of programming software (e.g., SAS/R) and industry requirements (e.g., CDISC, eCTD, Define.xml); attend functional meetings and training.
- Represent statistical programming at indication/program level in audits/inspections and Health Authority meetings; contribute to external conferences/consortiums.
- Provide expert technical recommendations and thought leadership for the Statistical Programming function and non-clinical initiatives.
Essential Requirements:
- BS/MS in life science, computer science, statistics, mathematics, or equivalent; 6+ years in a programming/statistical role.
- 3+ years leadership/line management experience (including matrix management for people managers); ability to manage multiple trials and meet deadlines.
- In-depth understanding of clinical trial methodology, regulatory requirements, and Good Clinical Practice (GCP).
- Expert in SAS or R; develop and validate deliverables in a Statistical Programming environment; create advanced MACROs and/or functions.
- Significant experience contributing to statistical analysis plans and developing technical programming specifications.
- Advanced knowledge of industry standards, including CDISC; understanding of development and use of standard programs.
- 2+ years as a Lead/Program/Project Programmer for programs/indications, coordinating large internal/external teams.
- Excellent interpersonal skills; ability to influence and communicate in a global environment with internal/external stakeholders.
Desired Requirements:
- 10+ years experience in a programming or statistical role (equivalent).
Benefits (as stated):
- Performance-based cash incentive; eligibility for annual equity awards depending on level.
- US-based eligible employees: comprehensive benefits package (health, life, disability), 401(k) with company contribution and match, and other benefits; time off (vacation, personal days, holidays, and other leaves).
Application instructions:
- Not specified in the provided text.