Principal Statistical Programmer – Rare Disease Biotech – North Carolina
Global Life Science Hub is working with a stimulating Biotechnology company based on the East Coast, developing novel therapeutics for extremely rare diseases. In the last 2 years, they have accomplished 150% growth from 120 employees to 350.
Their extraordinary growth has come from accomplishing their first approval for the US, EU and the Middle East. With the successful launch and achieving $160 million in revenue, they can continue focusing on the additional 4 promising compounds in their pipeline.
As part of their next stage of growth they are searching for a new Principal Programmer who is responsible for the design, development and implementation of technical solutions and will also have oversight of external vendors and members of cross-functional development teams.
- Leads and supports programming for clinical study reports, as needed, including oversight of statistical programming for outsourced trials. Meets regularly with CRO counterparts. Attends clinical study team meetings as needed.
- Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards
- Develops unambiguous and robust programming specifications (e.g. ADaM specifications
- Ensures that study documentation is maintained to the standard required according to SOPs and acceptable for audit.
- In collaboration with data management, may provide specialty SAS programming for data management including customized line listings to support review of clinical trial data.
- Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities
- Communicates proactively and effectively around issues and risks and contributes to its remediation
- BSc in a life Science area, preferably in Stats; MS is highly preferred.
- 8 years required in Pharma; have familiarity at Sponsor level in working w/ cross-functional groups (Safety, Clin Pharm)
- Function as Lead Programmer for 1 or more indications
- Must have extensive SDTM & ADaM datasets experience
- Clinical knowledge: would know eCRFs, DMPs, SAPs.
- Good track record of job performance & promotion at companies.
- Communication skills need to be fluid
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com