Manager, Statistical Programming

PTC Therapeutics • Warren, MI

3d

About The Position

The Manager, Statistical Programming performs programming activities for clinical development programs and associated studies, either directly or through oversight of Contract Research Organizations (CROs). The role contributes to timely statistical analyses of clinical data in accordance with protocols and Statistical Analysis Plans, including developing statistical programs and producing outputs used in integrated scientific reports of clinical trial results. The manager works across internal departments and with external resources on statistical programming matters, supports regulatory and company SOP compliance, and participates in the development and review of statistical programming procedures, processes, and biostatistics computing systems and applications as appropriate.

Requirements

• Bachelor’s degree in a quantitative sciences discipline, such as Statistics, Mathematics, or Computer Science.
• At least 5 years of experience in statistics or statistical programming in a pharmaceutical, biotechnology, CRO, or related environment.
• Demonstrated applied SAS programming skills, including Base SAS, SAS/Stat, SAS/Graph, SAS macros, and ODS.
• Good understanding of database systems.
• Working knowledge of R.
• Experience with Clinical Data Interchange Standards Consortium (CDISC) standards.
• Knowledge of clinical data analysis and reporting processes as they relate to drug development.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed environment with internal and external team members.
• Analytical thinking, excellent problem-solving skills, and ability to adapt to changing priorities and deadlines.
• Excellent planning, organization, and time-management skills, including the ability to support and prioritize multiple projects.

Nice To Haves

• Master’s degree in a quantitative discipline, such as Statistics, Mathematics, or Computer Science.
• Experience working with CROs.
• Experience supporting New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs) submissions.

Responsibilities

• Contribute to statistical programming activities for assigned clinical development studies and programs.
• Ensure timely statistical analyses of clinical data according to protocols and Statistical Analysis Plans, directly or through CRO oversight.
• Develop statistical programs and produce programmed outputs used to create integrated scientific reports of clinical trial results.
• Represent the Biostatistics function at study team meetings.
• Help identify statistical issues and collaborate with statistical programming team members to identify solutions.
• Act as a statistical and programming resource to development teams.
• Participate in assessment, selection, and evaluation of CROs.
• Participate in review of Case Report Forms (CRFs), CRF annotations, Statistical Action Plans, TLGs, and TLG shells.
• Interact with CROs involved in data management and analysis, as appropriate, to ensure analyses and outputs are accurate and consistent with agreed deliverables; work with vendor staff to characterize and resolve data-analysis issues.
• Create or review derived dataset specifications and related analysis datasets.
• Develop SOPs and training guidelines related to statistical programming, as appropriate.
• Perform other tasks and assignments as needed and specified by management.

Benefits

• Eligibility for short- and long-term incentives in addition to base salary.
• Eligible employees may enroll in medical, dental, vision, and retirement savings plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager