Senior Director, Statistical Programming

Your mission is to provide strategic and technical leadership for the statistical programming function driving the delivery of high-quality data and analysis for Bicycles clinical portfolio. You will ensure operational excellence across all programming activities serve as a key strategic partner to Biostatistics and Clinical Development and lead and mentor a team of programmers to support the successful execution of our clinical trials and regulatory submissions.

YOUR RESPONSIBILITIES  

Strategic & Technical Leadership

• Provide strategic leadership and hold accountability for all statistical programming deliverables for assigned clinical development programs ensuring timelines quality and compliance are met.
• Serve as the senior technical expert on CDISC standards (SDTM ADaM) programming methodologies and data submission strategies guiding the team and vendors on complex implementation challenges.
• Partner with the Biometrics Lead to define and execute the long-term vision and strategy for the statistical programming function including resource planning technology adoption and talent development.

Operational Excellence & Process Innovation

• Drive the strategy for functional excellence by developing implementing and optimizing global Standard Operating Procedures (SOPs) tools and innovative workflows to enhance efficiency and quality.
• Oversee the strategic selection and governance of CROs and external vendors ensuring a harmonized approach to programming and holding partners accountable for high-quality timely deliverables.
• Ensure all statistical programming activities and documentation are inspection-ready providing senior oversight for data integrity and demonstrable compliance with ICH/GCP guidelines.

Team Leadership & Development

• You will lead coach and mentor your team investing in their professional growth and fostering a culture of high performance and psychological safety.
• You will set clear goals and strategic priorities for your team ensuring their work is directly aligned with departmental and organisational objectives.
• You will champion the Bicycle Values in all that you do acting as a role model and embedding a culture of collaboration accountability and innovation within your team.

WHO ARE YOU: SKILLS & COMPETENCIES

Knowledge:

• You apply expert knowledge of statistical programming and clinical development to set functional strategy and solve complex multi-faceted problems. You have a deep understanding of the regulatory landscape and its impact on programming deliverables.

Job Complexity:

• You are accountable for managing a portfolio of complex clinical programs and addressing abstract challenges that require in-depth evaluation of variable factors. You anticipate future needs and develop innovative long-range solutions for the programming function.

Independence:

• You operate with a high degree of independence aligning your teams strategy with broader departmental and company goals. You are trusted to make significant decisions regarding project execution resource allocation and vendor management.

Values & Behaviours:

• You are a role model for the Bicycle Values leading by example to create an inclusive and high-performing team environment. You build strong influential relationships with senior stakeholders across the organization and represent the function with credibility.

Qualifications :

• Demonstrated deep expertise in statistical programming gained through significant and progressive experience in a biotech or pharmaceutical setting.
• Proven track record of leading the programming strategy for clinical development programs preferably within oncology.
• Expert-level knowledge of SAS programming and CDISC data standards (SDTM/ADaM) with extensive experience preparing data for regulatory submissions (e.g. NDA/BLA).
• Substantial experience in managing CROs and external vendors including technical oversight governance and relationship management.
• Proven leadership experience with the ability to mentor programmers set strategic direction for a team and influence cross-functional partners.

Additional Information :

• 401(k) plan with a 4% Company match and immediate vesting 
• Medical dental and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company 
• Health and Dependent Care Flexible Spending Accounts 
• Employee assistance program (EAP)
• Time off (eligibility to accrue up to 23 paid time off days per full year worked the option to buy up to 5 additional days & 10 company nominated holidays)
• 10 Company holidays 
• Competitive reward including annual company bonus 
• Employee recognition schemes
• Enhanced parental leave policies
• Flexible working environment
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. 

Compensation

• Salary Range: $215000 - $270000

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore all qualified applicants will be considered for employment and we do not discriminate on the basis of race religion colour gender sexual orientation age disability status marital status or veteran status.

Remote Work :

No

Employment Type :

Full-time