Senior Manager, Statistical Programming

Job Description

Job Description

About the position :

Responsible for the statistical programming function at Shattuck Labs to ensure statistical integrity, adequacy and accuracy of clinical studies / databases and to deliver high quality data package within the agreed upon timelines.

Perform statistical programming and data analyses in the support of product development including IND / CTA submissions.

Help to select, coordinate and manage external vendors supporting statistical programming. Maintain and improve professional knowledge of technological advancements in data manipulation and statistical analyses.

Train and manage staff (internal, contract, CRO) to support the statistical programming team as the organization grows.

Engage with clinical teams and served as the lead statistical programmer for clinical studies. Review statistical analysis plan and shells for tables, figures and listings.

Write, test and validate SAS programs to perform statistical analyses to analyze and report clinical trials data in table, listings and figures.

Write or review SDTM and ADaM dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed).

Perform ad hoc and exploratory statistical analyses as needed.

• Lead Quality Check activities to ensure high quality data output delivery.
• Provide oversight and supervision of relevant external consultants and clinical research organizations for outsourced statistical programming activities.

Manage CROs to analyze and report complex data in table, listings and figures, and for electronic submission of SDTM and ADaM in CDISC format.

• Ensure systems are in place to produce quality work efficiently. Evaluate workloads, resources, process, and technology, and prioritize projects / deliverables for efficient operation of the statistical programming function.
• Development of standard SAS programs, and standard statistical programming operating procedures as needed.
• Engage in regulatory submission as needed. Participate in the preparation of publications including manuscripts, posters and oral presentations.

Qualifications / requirements :

• 6+ years industry experience with Phase I to IV clinical trial data in biostatistics and statistical Programming; ability to efficiently manage several programs and protocols
• Working experience in CDISC standards including SDTM and ADaM data standards, creating define files, cSDRG, ADRG and oncology specific domains in SDTM, previous regulatory submission with CDISC package is preferred.
• Proficiency in SAS programming language.
• Management experience including managing QC process, external vendors / partners.
• A Master’s degree in Statistics or other related field with high statistical content.
• Experience in oncology clinical trials including hematological malignancy and solid tumor.
• Experience in PK data analysis including preparation of data for NONMEN analysis is preferred.

Additional skills / traits :

• Proficiency with SAS and other programming skills.
• Good communication and interpersonal skills and ability to work with cross-functional teams.
• Positive and collaborative attitude.
• Unrelenting dedication to delivering high quality results.
• Experience in statistical programming for oncology clinical trials.
• Deeply motivated self-starter with an entrepreneurial spirit.
• Good team player.
• Ability to work in a quickly changing, fast-paced environment, and to adapt and adjust to changing priorities.
• Manage multiple programs with competing and aggressive timelines, prioritize activities, and work independently.
30+ days ago